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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)

Primary Purpose

Solid Tumor.

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Blood sampling

About this trial

This is an interventional diagnostic trial for Solid Tumor.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Institut CurieRecruiting
Institut Mutualiste MontsourisRecruiting
Institut CurieRecruiting

Outcomes

Primary Outcome Measures

CTC, CEC or ctDNA incidence

number of CTC or CEC in 7.5ml of blood

Secondary Outcome Measures

CTC and CEC molecular characterization

This outcome is self-explanatory.

Circulating tumor DNA (ctDNA) detection and quantification

plasma mutation detection (number of copy)

Full Information

NCT ID

NCT02220556

First Posted

August 8, 2014

Last Updated

July 6, 2016

Sponsor

Institut Curie

1. Study Identification

Unique Protocol Identification Number

NCT02220556

Brief Title

Evaluation of Different Analysis Methods for Circulating Tumor Cells, Circulating Endothelial Cell, and Circulating Tumor DNA in Patient Followed for a Tumoral Pathology

Acronym

CTC-CEC-ADN

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 Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2010 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Curie

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Solid Tumor.

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

360 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Blood sampling

Primary Outcome Measure Information:

Title

CTC, CEC or ctDNA incidence

Description

number of CTC or CEC in 7.5ml of blood

Time Frame

3 years

Secondary Outcome Measure Information:

Title

CTC and CEC molecular characterization

Description

This outcome is self-explanatory.

Time Frame

3 years

Title

Circulating tumor DNA (ctDNA) detection and quantification

Description

plasma mutation detection (number of copy)

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Patricia Tresca, MD

Phone

+33 (0) 1 56.24.57.65

patricia.tresca@curie.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Yves Pierga, Prof.

Organizational Affiliation

Institut Curie

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

François-Clément Bidard, MD, PhD

Organizational Affiliation

Institut Curie

Official's Role

Study Chair

Facility Information:

Facility Name

Institut Curie

City

Paris

ZIP/Postal Code

75005

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Yves Pierga, Prof.

First Name & Middle Initial & Last Name & Degree

François-Clément Bidard, MD

Facility Name

Institut Mutualiste Montsouris

City

Paris

ZIP/Postal Code

75014

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christophe Louvet, Prof.

Facility Name

Institut Curie

City

Saint-Cloud

ZIP/Postal Code

92210

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emmanuel Mitry, Prof.

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Different Analysis Methods for Circulating Tumor Cells, Circulating Endothelial Cell, and Circulating Tumor DNA in Patient Followed for a Tumoral Pathology

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