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出境医 / 临床实验 / Molecular Analysis of Blood Samples in Standardized Cancer Care Referrals for SCAN and CUP

Molecular Analysis of Blood Samples in Standardized Cancer Care Referrals for SCAN and CUP

Study Description
Brief Summary:

Patients with suspected cancer (SCAN) and cancer of unknown primary tumor (CUP) are vulnerable because the investigation is difficult and expensive and have poor prognosis because few effective established curative treatments are available. Great progress has been made, for example through highly qualified and systematic clinical investigations not least within the framework of the standardized care processes. However, there is a need for faster, less invasive and more cost-effective tests to confirm or exclude the diagnosis of carcinoma (epithelial cancer), primarily for SCAN and secondly for CUP, and partly to receive suggestions for localization of the primary tumor for primarily CUP and secondly SCAN. There is also a need for prediction of molecularly targeted therapies.

New research provides opportunities for using a blood test to acquire detailed and updated information about the individual patient's disease and thus also open new opportunities for faster, less invasive and more cost-effective diagnosis and prediction of molecularly targeted treatments based on individualized sampling and molecular stratification. It is important that these opportunities are tested in a timely fashion in practical health care, so the new opportunities can be taken advantage of and developed in the best way. The aim is to establish a new "best practice" for these hard-to-study and difficult-to-treat patients.

Samples will be taken of epithelial cells circulating in the blood, and of the free circulating DNA.

As a reference, germ-line DNA will also be sampled, also from regular blood samples.

The analyses will show whether the cellular and molecular tests can work in the existing standardized care processes for SCAN and CUP, or if adaptations in routines, training or equipment need to be introduced.

The analyses will also give an indication of whether the cellular and molecular sample analyses provide practically useful information for confirming or refuting the diagnosis of cancer, suggesting from which organ the cancer originated and for predicting individualized therapies, and whether adaptations in routines, training or technology need to be introduced.


Condition or disease Intervention/treatment
Neoplasms, Unknown Primary Cancer Genetic: Circulating tumor cell and circulating tumor DNA test

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Value of Molecular Biological Analysis of Blood Samples in Standardized Care Procedures in Suspected Cancer (SCAN) and Cancer of Unknown Primary (CUP)
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Group/Cohort Intervention/treatment
Cancer of Unknown Primary (CUP)

Subjects referred, based on standardised criteria, for investigation and diagnosis for possible cancer of unknown primary (CUP).

Blood samples to be investigated for presence of circulating tumor cells and circulating tumor DNA.

 Genetic: Circulating tumor cell and circulating tumor DNA test
Patient stratification based on presence or absence of suspicious findings of cells and DNA
Suspected CANcer (SCAN)

Subjects referred, based on standardised criteria, for investigation and diagnosis for suspected cancer (SCAN) based on serious non-specific symptoms and signs of cancer.

Blood samples to be investigated for presence of circulating tumor cells and circulating tumor DNA.

 Genetic: Circulating tumor cell and circulating tumor DNA test
Patient stratification based on presence or absence of suspicious findings of cells and DNA
Outcome Measures
Primary Outcome Measures :
  1. Possibility of cellular and genomic sampling as part of the standardised care process [ Time Frame: 1 month ]
    Can blood samples be taken, processed in a timely manner and processed for isolation and analysis of circulating epithelial cells and free circulating DNA within the framework of the standardized care process for SCAN and CUP?


Secondary Outcome Measures :
  1. Cellular and genomic sample analyses [ Time Frame: 6 months ]
    Are the cellular and molecular sample analyses already practically useful for the universal confirmation or exclusion of the diagnosis of epithelial cancer, suggest from which anatomic location the cancer originated and predict individualised treatment, or should the test be re-focused on certain areas of diagnosis, or developed technically, in order to assist the diagnostic investigation and predict the treatment based on detailed information of the current state of the individual patient's disease?


Biospecimen Retention:   Samples With DNA
Peripheral blood samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 125 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who were referred to be investigated and diagnosed at the Diagnostic Centre (DC) in Södertälje, Sweden.
Criteria

Inclusion Criteria:

  • 200 patients who were referred to be investigated and diagnosed at the Diagnostic Centre (DC) in Södertälje, Sweden, for suspected cancer (SCAN) with serious non-specific symptoms with signs of cancer, or with suspected cancer of unknown primary (CUP) and which give informed consent to participate in the study.

Exclusion Criteria:

  • All patients who have been referred and consented are included.
Contacts and Locations

Contacts
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Contact: Roland Soderholm, MD 08-550 24493 roland.soderholm@sll.se

Locations
Layout table for location information
Sweden
Diagnostiskt Centrum, Södertälje Sjukhus Recruiting
Södertälje, Stockholm, Sweden, 152 86
Sponsors and Collaborators
Christer Ericsson
Karolinska Institutet
iCellate Medical
Investigators
Layout table for investigator information
Study Director: Charlotta Savblom, MD, PhD Region Stockholm
Principal Investigator: Christer Ericsson, PhD Karolinska Institutet
Tracking Information
First Submitted Date July 15, 2019
First Posted Date July 19, 2019
Last Update Posted Date October 4, 2019
Actual Study Start Date September 30, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 15, 2019) 		Possibility of cellular and genomic sampling as part of the standardised care process [ Time Frame: 1 month ]
Can blood samples be taken, processed in a timely manner and processed for isolation and analysis of circulating epithelial cells and free circulating DNA within the framework of the standardized care process for SCAN and CUP?
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 15, 2019) 		Cellular and genomic sample analyses [ Time Frame: 6 months ]
Are the cellular and molecular sample analyses already practically useful for the universal confirmation or exclusion of the diagnosis of epithelial cancer, suggest from which anatomic location the cancer originated and predict individualised treatment, or should the test be re-focused on certain areas of diagnosis, or developed technically, in order to assist the diagnostic investigation and predict the treatment based on detailed information of the current state of the individual patient's disease?
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Molecular Analysis of Blood Samples in Standardized Cancer Care Referrals for SCAN and CUP
Official Title The Value of Molecular Biological Analysis of Blood Samples in Standardized Care Procedures in Suspected Cancer (SCAN) and Cancer of Unknown Primary (CUP)
Brief Summary

Patients with suspected cancer (SCAN) and cancer of unknown primary tumor (CUP) are vulnerable because the investigation is difficult and expensive and have poor prognosis because few effective established curative treatments are available. Great progress has been made, for example through highly qualified and systematic clinical investigations not least within the framework of the standardized care processes. However, there is a need for faster, less invasive and more cost-effective tests to confirm or exclude the diagnosis of carcinoma (epithelial cancer), primarily for SCAN and secondly for CUP, and partly to receive suggestions for localization of the primary tumor for primarily CUP and secondly SCAN. There is also a need for prediction of molecularly targeted therapies.

New research provides opportunities for using a blood test to acquire detailed and updated information about the individual patient's disease and thus also open new opportunities for faster, less invasive and more cost-effective diagnosis and prediction of molecularly targeted treatments based on individualized sampling and molecular stratification. It is important that these opportunities are tested in a timely fashion in practical health care, so the new opportunities can be taken advantage of and developed in the best way. The aim is to establish a new "best practice" for these hard-to-study and difficult-to-treat patients.

Samples will be taken of epithelial cells circulating in the blood, and of the free circulating DNA.

As a reference, germ-line DNA will also be sampled, also from regular blood samples.

The analyses will show whether the cellular and molecular tests can work in the existing standardized care processes for SCAN and CUP, or if adaptations in routines, training or equipment need to be introduced.

The analyses will also give an indication of whether the cellular and molecular sample analyses provide practically useful information for confirming or refuting the diagnosis of cancer, suggesting from which organ the cancer originated and for predicting individualized therapies, and whether adaptations in routines, training or technology need to be introduced.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Peripheral blood samples
Sampling Method Probability Sample
Study Population Patients who were referred to be investigated and diagnosed at the Diagnostic Centre (DC) in Södertälje, Sweden.
Condition
  • Neoplasms, Unknown Primary
  • Cancer
Intervention Genetic: Circulating tumor cell and circulating tumor DNA test
Patient stratification based on presence or absence of suspicious findings of cells and DNA
Study Groups/Cohorts
  • Cancer of Unknown Primary (CUP)

    Subjects referred, based on standardised criteria, for investigation and diagnosis for possible cancer of unknown primary (CUP).

    Blood samples to be investigated for presence of circulating tumor cells and circulating tumor DNA.

    Intervention: Genetic: Circulating tumor cell and circulating tumor DNA test
  • Suspected CANcer (SCAN)

    Subjects referred, based on standardised criteria, for investigation and diagnosis for suspected cancer (SCAN) based on serious non-specific symptoms and signs of cancer.

    Blood samples to be investigated for presence of circulating tumor cells and circulating tumor DNA.

    Intervention: Genetic: Circulating tumor cell and circulating tumor DNA test
Publications *
  • Stenman E, Palmér K, Rydén S, Sävblom C, Svensson I, Rose C, Ji J, Nilbert M, Sundquist J. Diagnostic spectrum and time intervals in Sweden's first diagnostic center for patients with nonspecific symptoms of cancer. Acta Oncol. 2019 Mar;58(3):296-305. doi: 10.1080/0284186X.2018.1537506. Epub 2019 Jan 11.
  • Castro, J., Ericsson C., Cashin P., Mahteme H. Preliminary Finding: Detection of Circulating Cancer Cells in Blood from a Patient with Peritoneal Carcinomatosis Treated with Cytoreductive Surgery and Intraperitoneal Chemotherapy. Surgery: Current Research 2(3), 2012. doi: 10.4172/2161-1076.1000113
  • Castro, J., Sanchez, L., Alvarez Bedoya, P.H., Nunez, M.T., Lu, M., Castro, T., Sharifi, H.R., Ericsson, C. Screening Circulating Tumor Cells as a Non-invasive Cancer Test in 1,585 Asymptomatic Adults (ICELLATE1) J Integr Oncol 7(3), 2018 DOI 10.4172/2329-6771.1000212
  • Castro J, Sanchez L, Nuñez MT, Lu M, Castro T, Sharifi HR, Ericsson C. Screening Circulating Tumor Cells as a Noninvasive Cancer Test in 3388 Individuals from High-Risk Groups (ICELLATE2). Dis Markers. 2018 May 28;2018:4653109. doi: 10.1155/2018/4653109. eCollection 2018.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 15, 2019) 		200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 200 patients who were referred to be investigated and diagnosed at the Diagnostic Centre (DC) in Södertälje, Sweden, for suspected cancer (SCAN) with serious non-specific symptoms with signs of cancer, or with suspected cancer of unknown primary (CUP) and which give informed consent to participate in the study.

Exclusion Criteria:

  • All patients who have been referred and consented are included.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 125 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Roland Soderholm, MD 08-550 24493 roland.soderholm@sll.se
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT04025970
Other Study ID Numbers 2019-01410
Has Data Monitoring Committee Yes
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
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data (IPD) available to other researchers
Responsible Party Christer Ericsson, Stockholm County Council, Sweden
Study Sponsor Christer Ericsson
Collaborators
  • Karolinska Institutet
  • iCellate Medical
Investigators
Study Director: Charlotta Savblom, MD, PhD Region Stockholm
Principal Investigator: Christer Ericsson, PhD Karolinska Institutet
PRS Account Stockholm County Council, Sweden
Verification Date October 2019

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