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出境医 / 临床实验 / Feasibility of a New Technology for Isolating Circulating Tumour Cells (CTC-SMMiL-E)

Feasibility of a New Technology for Isolating Circulating Tumour Cells (CTC-SMMiL-E)

Study Description
Brief Summary:

This is a prospective interventional single-site research with a collection of biological samples.

The primary objective of the trial is to assess the ability of the "new technology" to isolating circulating tumor cells (CTC) in selected cancer patients.

Five groups will be constitued: at first the Group 0: Healthy volunteers included for the spike-in test; and then the four groups, Group1: Metastatic HER2-positive breast cancer; Group 2: Advanced CA-125 positive ovarian cancer; Group 3: Metastatic PSA-positive castrate-resistant prostate cancer; Group 4: Healthy volunteers included as control).

In each group, the percentage of cases with identified circulating tumor cells will be estimated.


Condition or disease Intervention/treatment Phase
HER2-positive Metastatic Breast Cancer Ovarian Cancer Hormone-resistant Prostate Cancer Circulating Tumor Cell Procedure: Blood sample collection Not Applicable

Detailed Description:

This is a prospective interventional single-site research with a collection of biological samples ("Recherche Impliquant la Personne Humaine de type 2" according to French legislation).

First, a cohort of 20 healthy volunteers (Group 0: Healthy volunteers included for the spike-in test) will be constituted for the spike-in-test.

Then, recruitment of the three groups of 14 patients each (Group1: Metastatic HER2-positive breast cancer; Group 2: Advanced CA-125 positive ovarian cancer; Group 3: Metastatic PSA-positive castrate-resistant prostate cancer) and the control group of 14 healthy volunteers (Group 4: Healthy volunteers included as control) will be done in parallel.

In each group, the percentage of cases with identified circulating tumor cells will be estimated. Success will be defined as follows: the new technique has isolated putative circulating cells that have been confirmed as tumor cells by the immuno-histochemistry approach.

Circulating tumor cells (CTC) will be identified as followed:

  • Group 1 - putative circulating cells isolated by the new technique must be tested as HER-2 positive using Fluorescence In Situ Hybridization (FISH) to be regarded as true CTC
  • Group 2 - putative circulating cells isolated by the new technique must be tested as CA 125-positive using immuno-histochemistry (IHC) to be regarded as true CTC
  • Group 3 - putative circulating cells isolated by the new technique must be tested as PSA-positive using IHC to be regarded as true CTC For the healthy volunteers included as controls, if putative circulating cells are observed, these healthy volunteers will be tested against the three markers (HER2, CA-125 and PSA).

Failure will be defined as follows: the technique failed to identify circulating tumor cells, either due to a technical issue, or because there was no cell identified by the new technique, or lastly because the identified cells were negative by the standard FISH or IHC technique.

The different characteristics of these cells will be described: size, cytological characteristics, number, etc.

Secondary collected samples will be frozen, and new technique for isolation of CTC will be applied a second time to describe the impact of freezing to the capacity for isolating the CTC.

The primary objective of the trial is to assess the ability of the "new technology" to isolating circulating tumor cells (CTC) in selected cancer patients.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility of a New Technology for Isolating Circulating Tumour Cells in Selected Cancer Patients and Healthy Volunteers
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: blood sample collection
For all participants whatever the group Groups 0 and 4: Healthy volunteers Group1: Metastatic HER2-positive breast cancer Group 2: Advanced CA-125 positive ovarian cancer Group 3: Metastatic PSA-positive castrate-resistant prostate cancer Participants will receive the following interventions because they are enrolled in the study: blood sample collection of 32mL (4x8mL in EDTA tubes)
 Procedure: Blood sample collection
A total volume of 32 ml of blood will be collected in each subject and separated in 4 10-mL EDTA vacutainer tubes EDTA tubes of 8 mL each.
Outcome Measures
Primary Outcome Measures :
  1. Percentage of cases with identified circulating tumor cells. [ Time Frame: within 24 hours after inclusion (blood sample collection) ]

    To assess the ability of the "new technology" to isolating circulating tumor cells (CTC) in selected cancer patients.

    In each group, the percentage of cases with identified circulating tumor cells will be estimated.

    Success: the technique has isolated putative circulating cells that have been confirmed as tumor cells by the immuno-histochemistry approach.

    Failure: the technique failed to identify circulating tumor cells, either due to a technical issue, or because there was no cell identified by the new technique, or lastly because the identified cells were negative by the standard FISH or IHC technique.

    To be regarded as true CTC, Putative circulating cells isolated by the new technique must be tested as:

    • HER-2 positive using Fluorescence In Situ Hybridization (FISH) (Group 1)
    • CA 125-positive using immuno-histochemistry (IHC) (Group 2)
    • PSA-positive using IHC (Group 3)


Secondary Outcome Measures :
  1. Description of the isolated circulating cell [ Time Frame: within 24 hours after inclusion (blood sample collection) ]

    Describe the different characteristics of these cells: size, cytological characteristics, number ...

    These informations will allow to characterize the isolated circulating cells.


  2. Percentage of cases with identified circulating tumor cells after frozen storage [ Time Frame: within 24 hours after inclusion (blood sample collection) ]

    To assess the ability of the new technology to isolating CTC

    As secondary collected, collected samples will be frozen, and new technique for isolation of CTC will be applied a second time to describe the impact of freezing to our capacity for isolating the CTC.

    In each group, the percentage of cases with identified circulating tumor cells will be estimated.

    To be regarded as true CTC, Putative circulating cells isolated by the new technique must be tested as:

    • HER-2 positive using Fluorescence In Situ Hybridization (FISH) (Group 1)
    • CA 125-positive using immuno-histochemistry (IHC) (Group 2)
    • PSA-positive using IHC (Group 3)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥ 18 years old
  • Registered with a social security system
  • Signed, IRB-approved written informed consent
  • Belonging to one of the following group:
  • Group 1 - HER-2 positive breast cancer, defined as followed: histologically-proven, HER-2 positive breast cancer, with metastasis (stage IV) requiring first-line treatment
  • Group 2 - Advanced ovarian cancer, defined as followed: histologically-proven, stage III or IV ovarian cancer requiring first-line chemotherapy
  • Group 3 - Metastatic prostate cancer, defined as followed: histologically-proven, stage IV, castrate-resistant prostate cancer requiring chemotherapy with docetaxel or treatment with 2nd generation hormonal therapy (e.g. enzalutamide or abiraterone)
  • Groups 0 and 4 - Healthy volunteers defined as followed: No prior personal history of malignant disease

Exclusion Criteria:

  • Pregnant or breastfeeding woman
  • Patient under guardianship or curatorship
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Marie Vanseymortier +33 (0)3 20 29 59 18 promotion@o-lambret.fr

Locations
Layout table for location information
France
Centre Oscar Lambret
Lille, France, 59020
Contact: Emilie KACZMAREK, MD    03 20 29 59 59    e-kaczmarek@o-lambret.fr   
Principal Investigator: Emilie KACZMAREK, MD         
Sub-Investigator: Audrey MAILLIEZ, MD         
Sub-Investigator: Nicolas PENEL, MD, PhD         
Sub-Investigator: Delphine HUDRY, MD         
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Layout table for investigator information
Principal Investigator: Emilie KACZMAREK, MD Medical Oncology Department - Centre Oscar Lambret
Tracking Information
First Submitted Date  ICMJE May 27, 2019
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date June 7, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019) 		Percentage of cases with identified circulating tumor cells. [ Time Frame: within 24 hours after inclusion (blood sample collection) ]
To assess the ability of the "new technology" to isolating circulating tumor cells (CTC) in selected cancer patients. In each group, the percentage of cases with identified circulating tumor cells will be estimated. Success: the technique has isolated putative circulating cells that have been confirmed as tumor cells by the immuno-histochemistry approach. Failure: the technique failed to identify circulating tumor cells, either due to a technical issue, or because there was no cell identified by the new technique, or lastly because the identified cells were negative by the standard FISH or IHC technique. To be regarded as true CTC, Putative circulating cells isolated by the new technique must be tested as:
  • HER-2 positive using Fluorescence In Situ Hybridization (FISH) (Group 1)
  • CA 125-positive using immuno-histochemistry (IHC) (Group 2)
  • PSA-positive using IHC (Group 3)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • Description of the isolated circulating cell [ Time Frame: within 24 hours after inclusion (blood sample collection) ]
    Describe the different characteristics of these cells: size, cytological characteristics, number ... These informations will allow to characterize the isolated circulating cells.
  • Percentage of cases with identified circulating tumor cells after frozen storage [ Time Frame: within 24 hours after inclusion (blood sample collection) ]
    To assess the ability of the new technology to isolating CTC As secondary collected, collected samples will be frozen, and new technique for isolation of CTC will be applied a second time to describe the impact of freezing to our capacity for isolating the CTC. In each group, the percentage of cases with identified circulating tumor cells will be estimated. To be regarded as true CTC, Putative circulating cells isolated by the new technique must be tested as:
    • HER-2 positive using Fluorescence In Situ Hybridization (FISH) (Group 1)
    • CA 125-positive using immuno-histochemistry (IHC) (Group 2)
    • PSA-positive using IHC (Group 3)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of a New Technology for Isolating Circulating Tumour Cells
Official Title  ICMJE Feasibility of a New Technology for Isolating Circulating Tumour Cells in Selected Cancer Patients and Healthy Volunteers
Brief Summary

This is a prospective interventional single-site research with a collection of biological samples.

The primary objective of the trial is to assess the ability of the "new technology" to isolating circulating tumor cells (CTC) in selected cancer patients.

Five groups will be constitued: at first the Group 0: Healthy volunteers included for the spike-in test; and then the four groups, Group1: Metastatic HER2-positive breast cancer; Group 2: Advanced CA-125 positive ovarian cancer; Group 3: Metastatic PSA-positive castrate-resistant prostate cancer; Group 4: Healthy volunteers included as control).

In each group, the percentage of cases with identified circulating tumor cells will be estimated.
Detailed Description

This is a prospective interventional single-site research with a collection of biological samples ("Recherche Impliquant la Personne Humaine de type 2" according to French legislation).

First, a cohort of 20 healthy volunteers (Group 0: Healthy volunteers included for the spike-in test) will be constituted for the spike-in-test.

Then, recruitment of the three groups of 14 patients each (Group1: Metastatic HER2-positive breast cancer; Group 2: Advanced CA-125 positive ovarian cancer; Group 3: Metastatic PSA-positive castrate-resistant prostate cancer) and the control group of 14 healthy volunteers (Group 4: Healthy volunteers included as control) will be done in parallel.

In each group, the percentage of cases with identified circulating tumor cells will be estimated. Success will be defined as follows: the new technique has isolated putative circulating cells that have been confirmed as tumor cells by the immuno-histochemistry approach.

Circulating tumor cells (CTC) will be identified as followed:

  • Group 1 - putative circulating cells isolated by the new technique must be tested as HER-2 positive using Fluorescence In Situ Hybridization (FISH) to be regarded as true CTC
  • Group 2 - putative circulating cells isolated by the new technique must be tested as CA 125-positive using immuno-histochemistry (IHC) to be regarded as true CTC
  • Group 3 - putative circulating cells isolated by the new technique must be tested as PSA-positive using IHC to be regarded as true CTC For the healthy volunteers included as controls, if putative circulating cells are observed, these healthy volunteers will be tested against the three markers (HER2, CA-125 and PSA).

Failure will be defined as follows: the technique failed to identify circulating tumor cells, either due to a technical issue, or because there was no cell identified by the new technique, or lastly because the identified cells were negative by the standard FISH or IHC technique.

The different characteristics of these cells will be described: size, cytological characteristics, number, etc.

Secondary collected samples will be frozen, and new technique for isolation of CTC will be applied a second time to describe the impact of freezing to the capacity for isolating the CTC.

The primary objective of the trial is to assess the ability of the "new technology" to isolating circulating tumor cells (CTC) in selected cancer patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • HER2-positive Metastatic Breast Cancer
  • Ovarian Cancer
  • Hormone-resistant Prostate Cancer
  • Circulating Tumor Cell
Intervention  ICMJE Procedure: Blood sample collection
A total volume of 32 ml of blood will be collected in each subject and separated in 4 10-mL EDTA vacutainer tubes EDTA tubes of 8 mL each.
Study Arms  ICMJE Experimental: blood sample collection
For all participants whatever the group Groups 0 and 4: Healthy volunteers Group1: Metastatic HER2-positive breast cancer Group 2: Advanced CA-125 positive ovarian cancer Group 3: Metastatic PSA-positive castrate-resistant prostate cancer Participants will receive the following interventions because they are enrolled in the study: blood sample collection of 32mL (4x8mL in EDTA tubes)
Intervention: Procedure: Blood sample collection
Publications *
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  • Allard WJ, Matera J, Miller MC, Repollet M, Connelly MC, Rao C, Tibbe AG, Uhr JW, Terstappen LW. Tumor cells circulate in the peripheral blood of all major carcinomas but not in healthy subjects or patients with nonmalignant diseases. Clin Cancer Res. 2004 Oct 15;10(20):6897-904.
  • Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91.
  • Cristofanilli M, Hayes DF, Budd GT, Ellis MJ, Stopeck A, Reuben JM, Doyle GV, Matera J, Allard WJ, Miller MC, Fritsche HA, Hortobagyi GN, Terstappen LW. Circulating tumor cells: a novel prognostic factor for newly diagnosed metastatic breast cancer. J Clin Oncol. 2005 Mar 1;23(7):1420-30. Erratum in: J Clin Oncol. 2005 Jul 20;23(21):4808.
  • Riethdorf S, Fritsche H, Müller V, Rau T, Schindlbeck C, Rack B, Janni W, Coith C, Beck K, Jänicke F, Jackson S, Gornet T, Cristofanilli M, Pantel K. Detection of circulating tumor cells in peripheral blood of patients with metastatic breast cancer: a validation study of the CellSearch system. Clin Cancer Res. 2007 Feb 1;13(3):920-8.
  • Yagata H, Nakamura S, Toi M, Bando H, Ohno S, Kataoka A. Evaluation of circulating tumor cells in patients with breast cancer: multi-institutional clinical trial in Japan. Int J Clin Oncol. 2008 Jun;13(3):252-6. doi: 10.1007/s10147-007-0748-9. Epub 2008 Jun 14.
  • Kurihara T, Itoi T, Sofuni A, Itokawa F, Tsuchiya T, Tsuji S, Ishii K, Ikeuchi N, Tsuchida A, Kasuya K, Kawai T, Sakai Y, Moriyasu F. Detection of circulating tumor cells in patients with pancreatic cancer: a preliminary result. J Hepatobiliary Pancreat Surg. 2008;15(2):189-95. doi: 10.1007/s00534-007-1250-5. Epub 2008 Apr 6.
  • Khoja L, Backen A, Sloane R, Menasce L, Ryder D, Krebs M, Board R, Clack G, Hughes A, Blackhall F, Valle JW, Dive C. A pilot study to explore circulating tumour cells in pancreatic cancer as a novel biomarker. Br J Cancer. 2012 Jan 31;106(3):508-16. doi: 10.1038/bjc.2011.545. Epub 2011 Dec 20.
  • Maheswaran S, Sequist LV, Nagrath S, Ulkus L, Brannigan B, Collura CV, Inserra E, Diederichs S, Iafrate AJ, Bell DW, Digumarthy S, Muzikansky A, Irimia D, Settleman J, Tompkins RG, Lynch TJ, Toner M, Haber DA. Detection of mutations in EGFR in circulating lung-cancer cells. N Engl J Med. 2008 Jul 24;359(4):366-77. doi: 10.1056/NEJMoa0800668. Epub 2008 Jul 2.
  • Nagrath S, Sequist LV, Maheswaran S, Bell DW, Irimia D, Ulkus L, Smith MR, Kwak EL, Digumarthy S, Muzikansky A, Ryan P, Balis UJ, Tompkins RG, Haber DA, Toner M. Isolation of rare circulating tumour cells in cancer patients by microchip technology. Nature. 2007 Dec 20;450(7173):1235-9.
  • Stott SL, Hsu CH, Tsukrov DI, Yu M, Miyamoto DT, Waltman BA, Rothenberg SM, Shah AM, Smas ME, Korir GK, Floyd FP Jr, Gilman AJ, Lord JB, Winokur D, Springer S, Irimia D, Nagrath S, Sequist LV, Lee RJ, Isselbacher KJ, Maheswaran S, Haber DA, Toner M. Isolation of circulating tumor cells using a microvortex-generating herringbone-chip. Proc Natl Acad Sci U S A. 2010 Oct 26;107(43):18392-7. doi: 10.1073/pnas.1012539107. Epub 2010 Oct 7.
  • Stott SL, Lee RJ, Nagrath S, Yu M, Miyamoto DT, Ulkus L, Inserra EJ, Ulman M, Springer S, Nakamura Z, Moore AL, Tsukrov DI, Kempner ME, Dahl DM, Wu CL, Iafrate AJ, Smith MR, Tompkins RG, Sequist LV, Toner M, Haber DA, Maheswaran S. Isolation and characterization of circulating tumor cells from patients with localized and metastatic prostate cancer. Sci Transl Med. 2010 Mar 31;2(25):25ra23. doi: 10.1126/scitranslmed.3000403.
  • Cen P, Ni X, Yang J, Graham DY, Li M. Circulating tumor cells in the diagnosis and management of pancreatic cancer. Biochim Biophys Acta. 2012 Dec;1826(2):350-6. doi: 10.1016/j.bbcan.2012.05.007. Epub 2012 Jun 7. Review.
  • Soeth E, Grigoleit U, Moellmann B, Röder C, Schniewind B, Kremer B, Kalthoff H, Vogel I. Detection of tumor cell dissemination in pancreatic ductal carcinoma patients by CK 20 RT-PCR indicates poor survival. J Cancer Res Clin Oncol. 2005 Oct;131(10):669-76. Epub 2005 Sep 1.
  • Hoffmann K, Kerner C, Wilfert W, Mueller M, Thiery J, Hauss J, Witzigmann H. Detection of disseminated pancreatic cells by amplification of cytokeratin-19 with quantitative RT-PCR in blood, bone marrow and peritoneal lavage of pancreatic carcinoma patients. World J Gastroenterol. 2007 Jan 14;13(2):257-63.
  • de Albuquerque A, Kubisch I, Breier G, Stamminger G, Fersis N, Eichler A, Kaul S, Stölzel U. Multimarker gene analysis of circulating tumor cells in pancreatic cancer patients: a feasibility study. Oncology. 2012;82(1):3-10. doi: 10.1159/000335479. Epub 2012 Jan 20.
  • Alix-Panabières C, Pantel K. Circulating tumor cells: liquid biopsy of cancer. Clin Chem. 2013 Jan;59(1):110-8. doi: 10.1373/clinchem.2012.194258. Epub 2012 Sep 26. Review.
  • Pantel K, Speicher MR. The biology of circulating tumor cells. Oncogene. 2016 Mar 10;35(10):1216-24. doi: 10.1038/onc.2015.192. Epub 2015 Jun 8. Review.
  • Smerage JB, Barlow WE, Hortobagyi GN, Winer EP, Leyland-Jones B, Srkalovic G, Tejwani S, Schott AF, O'Rourke MA, Lew DL, Doyle GV, Gralow JR, Livingston RB, Hayes DF. Circulating tumor cells and response to chemotherapy in metastatic breast cancer: SWOG S0500. J Clin Oncol. 2014 Nov 1;32(31):3483-9. doi: 10.1200/JCO.2014.56.2561. Epub 2014 Jun 2.
  • Wan L, Pantel K, Kang Y. Tumor metastasis: moving new biological insights into the clinic. Nat Med. 2013 Nov;19(11):1450-64. doi: 10.1038/nm.3391. Review.
  • Gorges TM, Kuske A, Röck K, Mauermann O, Müller V, Peine S, Verpoort K, Novosadova V, Kubista M, Riethdorf S, Pantel K. Accession of Tumor Heterogeneity by Multiplex Transcriptome Profiling of Single Circulating Tumor Cells. Clin Chem. 2016 Nov;62(11):1504-1515. Epub 2016 Sep 14.
  • Zhang Z, Shiratsuchi H, Palanisamy N, Nagrath S, Ramnath N. Expanded Circulating Tumor Cells from a Patient with ALK-Positive Lung Cancer Present with EML4-ALK Rearrangement Along with Resistance Mutation and Enable Drug Sensitivity Testing: A Case Study. J Thorac Oncol. 2017 Feb;12(2):397-402. doi: 10.1016/j.jtho.2016.07.027. Epub 2016 Aug 6.
  • Jordan NV, Bardia A, Wittner BS, Benes C, Ligorio M, Zheng Y, Yu M, Sundaresan TK, Licausi JA, Desai R, O'Keefe RM, Ebright RY, Boukhali M, Sil S, Onozato ML, Iafrate AJ, Kapur R, Sgroi D, Ting DT, Toner M, Ramaswamy S, Haas W, Maheswaran S, Haber DA. HER2 expression identifies dynamic functional states within circulating breast cancer cells. Nature. 2016 Sep 1;537(7618):102-106. doi: 10.1038/nature19328. Epub 2016 Aug 24.
  • van de Stolpe A, Pantel K, Sleijfer S, Terstappen LW, den Toonder JM. Circulating tumor cell isolation and diagnostics: toward routine clinical use. Cancer Res. 2011 Sep 15;71(18):5955-60. doi: 10.1158/0008-5472.CAN-11-1254. Epub 2011 Sep 6.
  • Gorges TM, Tinhofer I, Drosch M, Röse L, Zollner TM, Krahn T, von Ahsen O. Circulating tumour cells escape from EpCAM-based detection due to epithelial-to-mesenchymal transition. BMC Cancer. 2012 May 16;12:178. doi: 10.1186/1471-2407-12-178.
  • Vila A, Abal M, Muinelo-Romay L, Rodriguez-Abreu C, Rivas J, López-López R, Costa C. EGFR-Based Immunoisolation as a Recovery Target for Low-EpCAM CTC Subpopulation. PLoS One. 2016 Oct 6;11(10):e0163705. doi: 10.1371/journal.pone.0163705. eCollection 2016.
  • Mostert B, Kraan J, Bolt-de Vries J, van der Spoel P, Sieuwerts AM, Schutte M, Timmermans AM, Foekens R, Martens JW, Gratama JW, Foekens JA, Sleijfer S. Detection of circulating tumor cells in breast cancer may improve through enrichment with anti-CD146. Breast Cancer Res Treat. 2011 May;127(1):33-41. doi: 10.1007/s10549-010-0879-y. Epub 2010 Apr 9.
  • Alunni-Fabbroni M, Sandri MT. Circulating tumour cells in clinical practice: Methods of detection and possible characterization. Methods. 2010 Apr;50(4):289-97. doi: 10.1016/j.ymeth.2010.01.027. Epub 2010 Jan 29. Review.
  • Lowes LE, Allan AL. Recent advances in the molecular characterization of circulating tumor cells. Cancers (Basel). 2014 Mar 13;6(1):595-624. doi: 10.3390/cancers6010595.
  • Vona G, Sabile A, Louha M, Sitruk V, Romana S, Schütze K, Capron F, Franco D, Pazzagli M, Vekemans M, Lacour B, Bréchot C, Paterlini-Bréchot P. Isolation by size of epithelial tumor cells : a new method for the immunomorphological and molecular characterization of circulatingtumor cells. Am J Pathol. 2000 Jan;156(1):57-63.
  • Farace F, Massard C, Vimond N, Drusch F, Jacques N, Billiot F, Laplanche A, Chauchereau A, Lacroix L, Planchard D, Le Moulec S, André F, Fizazi K, Soria JC, Vielh P. A direct comparison of CellSearch and ISET for circulating tumour-cell detection in patients with metastatic carcinomas. Br J Cancer. 2011 Sep 6;105(6):847-53. doi: 10.1038/bjc.2011.294. Epub 2011 Aug 9.
  • Zheng S, Lin HK, Lu B, Williams A, Datar R, Cote RJ, Tai YC. 3D microfilter device for viable circulating tumor cell (CTC) enrichment from blood. Biomed Microdevices. 2011 Feb;13(1):203-13. doi: 10.1007/s10544-010-9485-3.
  • Karabacak NM, Spuhler PS, Fachin F, Lim EJ, Pai V, Ozkumur E, Martel JM, Kojic N, Smith K, Chen PI, Yang J, Hwang H, Morgan B, Trautwein J, Barber TA, Stott SL, Maheswaran S, Kapur R, Haber DA, Toner M. Microfluidic, marker-free isolation of circulating tumor cells from blood samples. Nat Protoc. 2014 Mar;9(3):694-710. doi: 10.1038/nprot.2014.044. Epub 2014 Feb 27.
  • Ozkumur E, Shah AM, Ciciliano JC, Emmink BL, Miyamoto DT, Brachtel E, Yu M, Chen PI, Morgan B, Trautwein J, Kimura A, Sengupta S, Stott SL, Karabacak NM, Barber TA, Walsh JR, Smith K, Spuhler PS, Sullivan JP, Lee RJ, Ting DT, Luo X, Shaw AT, Bardia A, Sequist LV, Louis DN, Maheswaran S, Kapur R, Haber DA, Toner M. Inertial focusing for tumor antigen-dependent and -independent sorting of rare circulating tumor cells. Sci Transl Med. 2013 Apr 3;5(179):179ra47. doi: 10.1126/scitranslmed.3005616.
  • Jaeger BAS, Neugebauer J, Andergassen U, Melcher C, Schochter F, Mouarrawy D, Ziemendorff G, Clemens M, V Abel E, Heinrich G, Schueller K, Schneeweiss A, Fasching P, Beckmann MW, Scholz C, Friedl TWP, Friese K, Pantel K, Fehm T, Janni W, Rack B. The HER2 phenotype of circulating tumor cells in HER2-positive early breast cancer: A translational research project of a prospective randomized phase III trial. PLoS One. 2017 Jun 6;12(6):e0173593. doi: 10.1371/journal.pone.0173593. eCollection 2017.
  • Zhang S, Li L, Wang T, Bian L, Hu H, Xu C, Liu B, Liu Y, Cristofanilli M, Jiang Z. Real-time HER2 status detected on circulating tumor cells predicts different outcomes of anti-HER2 therapy in histologically HER2-positive metastatic breast cancer patients. BMC Cancer. 2016 Jul 25;16:526. doi: 10.1186/s12885-016-2578-5.
  • Agelaki S, Kalykaki A, Markomanolaki H, Papadaki MA, Kallergi G, Hatzidaki D, Kalbakis K, Mavroudis D, Georgoulias V. Efficacy of Lapatinib in Therapy-Resistant HER2-Positive Circulating Tumor Cells in Metastatic Breast Cancer. PLoS One. 2015 Jun 17;10(6):e0123683. doi: 10.1371/journal.pone.0123683. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2019) 		76
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years old
  • Registered with a social security system
  • Signed, IRB-approved written informed consent
  • Belonging to one of the following group:
  • Group 1 - HER-2 positive breast cancer, defined as followed: histologically-proven, HER-2 positive breast cancer, with metastasis (stage IV) requiring first-line treatment
  • Group 2 - Advanced ovarian cancer, defined as followed: histologically-proven, stage III or IV ovarian cancer requiring first-line chemotherapy
  • Group 3 - Metastatic prostate cancer, defined as followed: histologically-proven, stage IV, castrate-resistant prostate cancer requiring chemotherapy with docetaxel or treatment with 2nd generation hormonal therapy (e.g. enzalutamide or abiraterone)
  • Groups 0 and 4 - Healthy volunteers defined as followed: No prior personal history of malignant disease

Exclusion Criteria:

  • Pregnant or breastfeeding woman
  • Patient under guardianship or curatorship
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Marie Vanseymortier +33 (0)3 20 29 59 18 promotion@o-lambret.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03979339
Other Study ID Numbers  ICMJE CTC-SMMiL-E-1901
2019-A01187-50 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Oscar Lambret
Study Sponsor  ICMJE Centre Oscar Lambret
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emilie KACZMAREK, MD Medical Oncology Department - Centre Oscar Lambret
PRS Account Centre Oscar Lambret
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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