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出境医 / 临床实验 / Development of a Cinical and Biological Database in Ovarian, Fallopian Tube and Peritoneal Cancers (BCBOvaire)

Development of a Cinical and Biological Database in Ovarian, Fallopian Tube and Peritoneal Cancers (BCBOvaire)

Study Description
Brief Summary:
A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical datas to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to epithetial ovarian cancer, Fallopian tube cancer and Primitive peritoneal cancer.

Condition or disease Intervention/treatment Phase
Carcinoma, Ovarian Epithelial Fallopian Tube Neoplasms Peritoneal Neoplasms Other: Biological collection Not Applicable

Detailed Description:

A Clinical and Biological Database is a collection of reliable, prospective and representative datas.

This collection, provided to the scientific community, will help to develope research programs such as :

  • Cinicals and biological predictive factors of treatments response
  • Identification of biological tumoral markers associate with survival
  • Identification of prognosic factors after recidivism
  • Diagnostics tests optimisation and follow-up from blood samples ( Circulating Tumor Cells (CTC) )
  • Developing strong preclinical models. Those models would be later used to test alternative treatments and would help to identify new biomarkers
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Development of a Prospective and Monocentric Cinical and Biological Database in Epithelial Ovarian Cancer, Fallopian Tube Cancer and Primitive Peritoneal Cancer
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2027
Arms and Interventions
Arm Intervention/treatment
Experimental: Biological collection

For all the patients include in the studie :

  • Blood samples collected at different times : Before treatment (T1) , after chemotherapy (T2), after interval surgery (T3) and after cancer reccurence (T4)
  • Tissue samples (tumor tissue and healthy tissue) collected during the surgery

In parallel to this biological collection, standardized clinical data will be entered into a database

 Other: Biological collection
  • Blood samples collected at different times : Before treatment (T1) , after chemotherapy (T2), after interval surgery (T3) and after cancer reccurence (T4)
  • Tissue samples (tumor tissue and healthy tissue) collected during the surgery
Outcome Measures
Primary Outcome Measures :
  1. Proportion of patients who gave their consent to participate in the study [ Time Frame: Until the study completion : 3 years ]
    The proportion of patients who consent to participate in the study among the screened patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 or older
  • Patient at the diagnosis of an epithelial ovarian cancer, or a fallopian tube caner or a primitive peritoneal cancer
  • Patient eligible for, at least, one surgery and a chemotherapy
  • Patient having given his informed, written and express consent

Exclusion Criteria:

  • Patient not affiliated to a social protection scheme
  • Pregnant and / or nursing women
  • Subject under tutelage, curatorship or safeguard of justice
  • Patient whose regular follow-up is impossible for psychological, familial, social or geographical reasons
Contacts and Locations

Contacts
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Contact: BLEUSE Jean-Pierre, M.D +33 4 67 61 31 02 DRCI-icm105@icm.unicancer.fr

Locations
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France
ICM - Institut régional du Cancer Montpellier Recruiting
Montpellier, France, 34298
Contact: BLEUSE Jean-Pierre, MD    0467613102 ext +33    jean-pierre.bleuse@icm.unicancer.fr   
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
Layout table for investigator information
Principal Investigator: COLOMBO Pierre-Emmanuel, M.D ICM - Institut régional du Cancer Montpellier
Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date August 4, 2020
Actual Study Start Date  ICMJE July 5, 2017
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019) 		Proportion of patients who gave their consent to participate in the study [ Time Frame: Until the study completion : 3 years ]
The proportion of patients who consent to participate in the study among the screened patients
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Development of a Cinical and Biological Database in Ovarian, Fallopian Tube and Peritoneal Cancers
Official Title  ICMJE Development of a Prospective and Monocentric Cinical and Biological Database in Epithelial Ovarian Cancer, Fallopian Tube Cancer and Primitive Peritoneal Cancer
Brief Summary A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical datas to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to epithetial ovarian cancer, Fallopian tube cancer and Primitive peritoneal cancer.
Detailed Description

A Clinical and Biological Database is a collection of reliable, prospective and representative datas.

This collection, provided to the scientific community, will help to develope research programs such as :

  • Cinicals and biological predictive factors of treatments response
  • Identification of biological tumoral markers associate with survival
  • Identification of prognosic factors after recidivism
  • Diagnostics tests optimisation and follow-up from blood samples ( Circulating Tumor Cells (CTC) )
  • Developing strong preclinical models. Those models would be later used to test alternative treatments and would help to identify new biomarkers
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
  • Carcinoma, Ovarian Epithelial
  • Fallopian Tube Neoplasms
  • Peritoneal Neoplasms
Intervention  ICMJE Other: Biological collection
  • Blood samples collected at different times : Before treatment (T1) , after chemotherapy (T2), after interval surgery (T3) and after cancer reccurence (T4)
  • Tissue samples (tumor tissue and healthy tissue) collected during the surgery
Study Arms  ICMJE Experimental: Biological collection

For all the patients include in the studie :

  • Blood samples collected at different times : Before treatment (T1) , after chemotherapy (T2), after interval surgery (T3) and after cancer reccurence (T4)
  • Tissue samples (tumor tissue and healthy tissue) collected during the surgery

In parallel to this biological collection, standardized clinical data will be entered into a database

Intervention: Other: Biological collection
Publications *
  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7.
  • Bolton KL, Chenevix-Trench G, Goh C, Sadetzki S, Ramus SJ, Karlan BY, Lambrechts D, Despierre E, Barrowdale D, McGuffog L, Healey S, Easton DF, Sinilnikova O, Benítez J, García MJ, Neuhausen S, Gail MH, Hartge P, Peock S, Frost D, Evans DG, Eeles R, Godwin AK, Daly MB, Kwong A, Ma ES, Lázaro C, Blanco I, Montagna M, D'Andrea E, Nicoletto MO, Johnatty SE, Kjær SK, Jensen A, Høgdall E, Goode EL, Fridley BL, Loud JT, Greene MH, Mai PL, Chetrit A, Lubin F, Hirsh-Yechezkel G, Glendon G, Andrulis IL, Toland AE, Senter L, Gore ME, Gourley C, Michie CO, Song H, Tyrer J, Whittemore AS, McGuire V, Sieh W, Kristoffersson U, Olsson H, Borg Å, Levine DA, Steele L, Beattie MS, Chan S, Nussbaum RL, Moysich KB, Gross J, Cass I, Walsh C, Li AJ, Leuchter R, Gordon O, Garcia-Closas M, Gayther SA, Chanock SJ, Antoniou AC, Pharoah PD; EMBRACE; kConFab Investigators; Cancer Genome Atlas Research Network. Association between BRCA1 and BRCA2 mutations and survival in women with invasive epithelial ovarian cancer. JAMA. 2012 Jan 25;307(4):382-90. doi: 10.1001/jama.2012.20.
  • Colombo PE, Fabbro M, Theillet C, Bibeau F, Rouanet P, Ray-Coquard I. Sensitivity and resistance to treatment in the primary management of epithelial ovarian cancer. Crit Rev Oncol Hematol. 2014 Feb;89(2):207-16. doi: 10.1016/j.critrevonc.2013.08.017. Epub 2013 Sep 8. Review.
  • Yang D, Khan S, Sun Y, Hess K, Shmulevich I, Sood AK, Zhang W. Association of BRCA1 and BRCA2 mutations with survival, chemotherapy sensitivity, and gene mutator phenotype in patients with ovarian cancer. JAMA. 2011 Oct 12;306(14):1557-65. doi: 10.1001/jama.2011.1456. Erratum in: JAMA. 2012 Jan 25;307(4):363.

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2019) 		150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2027
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 or older
  • Patient at the diagnosis of an epithelial ovarian cancer, or a fallopian tube caner or a primitive peritoneal cancer
  • Patient eligible for, at least, one surgery and a chemotherapy
  • Patient having given his informed, written and express consent

Exclusion Criteria:

  • Patient not affiliated to a social protection scheme
  • Pregnant and / or nursing women
  • Subject under tutelage, curatorship or safeguard of justice
  • Patient whose regular follow-up is impossible for psychological, familial, social or geographical reasons
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BLEUSE Jean-Pierre, M.D +33 4 67 61 31 02 DRCI-icm105@icm.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03976999
Other Study ID Numbers  ICMJE ICM-BDD2016/04
2016-A01041-50 ( Registry Identifier: N° ID RCB )
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 Institut du Cancer de Montpellier - Val d'Aurelle
Study Sponsor  ICMJE Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: COLOMBO Pierre-Emmanuel, M.D ICM - Institut régional du Cancer Montpellier
PRS Account Institut du Cancer de Montpellier - Val d'Aurelle
Verification Date August 2020

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

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