- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02220556
Evaluation of Different Analysis Methods for Circulating Tumor Cells, Circulating Endothelial Cell, and Circulating Tumor DNA in Patient Followed for a Tumoral Pathology (CTC-CEC-ADN)
August 7, 2025 updated by: Institut Curie
Fifteen cohorts will be opened.
Each cohort will explore one analysis method and/or tumoral type.
Up to 50 patient can be included into each cohort.
Study Overview
Study Type
Interventional
Enrollment (Actual)
360
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Paris, France, 75014
- Institut Mutualiste Montsouris
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Paris, France, 75005
- Institut Curie
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Saint-Cloud, France, 92210
- Institut Curie
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18 years old or more
- Performance status from 0 to 4
- Patient treated followed for histologically confirmed solid tumor type of any of these localization : breast, prostate, uterus, ovary, colon, lung, head and neck, melanoma.
- Informed consent form signed.
Exclusion Criteria:
- Patient with history of other invasive cancer within 5 years.
- Patient treated for any non-invasive cancer
- Patient individually deprived of liberty or placed under the authority of a tutor
- Geographical condition potentially preventing compliance with the study protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CTC, CEC or ctDNA incidence
Time Frame: 3 years
|
number of CTC or CEC in 7.5ml of blood
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CTC and CEC molecular characterization
Time Frame: 3 years
|
This outcome is self-explanatory.
|
3 years
|
|
Circulating tumor DNA (ctDNA) detection and quantification
Time Frame: 3 years
|
plasma mutation detection (number of copy)
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jean-Yves Pierga, Prof., Institut Curie
- Study Chair: François-Clément Bidard, MD, PhD, Institut Curie
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cabel L, Decraene C, Bieche I, Pierga JY, Bennamoun M, Fuks D, Ferraz JM, Lefevre M, Baulande S, Bernard V, Vacher S, Mariani P, Proudhon C, Bidard FC, Louvet C. Limited Sensitivity of Circulating Tumor DNA Detection by Droplet Digital PCR in Non-Metastatic Operable Gastric Cancer Patients. Cancers (Basel). 2019 Mar 21;11(3):396. doi: 10.3390/cancers11030396.
- Cabel L, Jeannot E, Bieche I, Vacher S, Callens C, Bazire L, Morel A, Bernard-Tessier A, Chemlali W, Schnitzler A, Lievre A, Otz J, Minsat M, Vincent-Salomon A, Pierga JY, Buecher B, Mariani P, Proudhon C, Bidard FC, Cacheux W. Prognostic Impact of Residual HPV ctDNA Detection after Chemoradiotherapy for Anal Squamous Cell Carcinoma. Clin Cancer Res. 2018 Nov 15;24(22):5767-5771. doi: 10.1158/1078-0432.CCR-18-0922. Epub 2018 Jul 27.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
August 8, 2014
First Submitted That Met QC Criteria
August 18, 2014
First Posted (Estimated)
August 20, 2014
Study Record Updates
Last Update Posted (Actual)
August 8, 2025
Last Update Submitted That Met QC Criteria
August 7, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IC 2010-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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