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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)

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ClinicalTrials.gov Identifier: NCT02220556
Recruitment Status : Unknown
Verified July 2016 by Institut Curie.
Recruitment status was:  Recruiting
First Posted : August 20, 2014
Last Update Posted : July 7, 2016
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumor. Procedure: Blood sampling Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Different Analysis Methods for Circulating Tumor Cells, Circulating Endothelial Cell, and Circulating Tumor DNA in Patient Followed for a Tumoral Pathology
Study Start Date : December 2010
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017



Primary Outcome Measures :
  1. CTC, CEC or ctDNA incidence [ Time Frame: 3 years ]
    number of CTC or CEC in 7.5ml of blood


Secondary Outcome Measures :
  1. CTC and CEC molecular characterization [ Time Frame: 3 years ]
    This outcome is self-explanatory.

  2. Circulating tumor DNA (ctDNA) detection and quantification [ Time Frame: 3 years ]
    plasma mutation detection (number of copy)



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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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220556


Contacts
Contact: Patricia Tresca, MD +33 (0) 1 56.24.57.65 patricia.tresca@curie.fr

Locations
France
Institut Curie Recruiting
Paris, France, 75005
Principal Investigator: Jean-Yves Pierga, Prof.         
Sub-Investigator: François-Clément Bidard, MD         
Institut Mutualiste Montsouris Recruiting
Paris, France, 75014
Principal Investigator: Christophe Louvet, Prof.         
Institut Curie Recruiting
Saint-Cloud, France, 92210
Principal Investigator: Emmanuel Mitry, Prof.         
Sponsors and Collaborators
Institut Curie
Investigators
Principal Investigator: Jean-Yves Pierga, Prof. Institut Curie
Study Chair: François-Clément Bidard, MD, PhD Institut Curie

Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT02220556     History of Changes
Other Study ID Numbers: IC 2010-01
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Neoplastic Cells, Circulating
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes