Back to resultsMeasurement and Characterization of Circulating Endothelial Cells or Circulating Tumor Cells or Circulating DNA in Adult Patients With Metastatic Cancer (Liquid Biopsy)
Primary Purpose
Metastatic Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples
Sponsored by
About this trial
This is an interventional diagnostic trial for Metastatic Cancer focused on measuring Patients
Eligibility Criteria
Inclusion Criteria:
- Patients with metastatic solid tumor
- Age> 18 years
- Signed consent
Exclusion Criteria:
- Patients with diseases associated with vascular lesions known.
- Patients protected by law, in accordance with Articles L1121-5 to L1121-8 of the Code of Public Health.
- Mental pathology that can interfere with the proper conduct of the study.
- Refusal of consent.
Sites / Locations
- Gustave Roussy Cancer Campus Grand ParisRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with metastatic cancer
Arm Description
Outcomes
Primary Outcome Measures
Measurement and characterization of CEC and CEP and circulaing DNA rate using flow cytometry
Measurement and characterization of initial CEC and CEP circulaing DNA and their evolution under treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT02666612
First Posted
August 12, 2015
Last Updated
January 25, 2017
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
1. Study Identification
Unique Protocol Identification Number
NCT02666612
Brief Title
Measurement and Characterization of Circulating Endothelial Cells or Circulating Tumor Cells or Circulating DNA in Adult Patients With Metastatic Cancer
Acronym
Liquid Biopsy
Official Title
Measurement and Characterization of Circulating Endothelial Cells or Circulating Tumor Cells or Circulating DNA in Adult Patients With Metastatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Monitoring of circulating endothelial cells (CEC and mature cells called progenitors called CEP) or circulating tumor cells (CTC) in adult patients with metastatic cancer, possibly treated with targeted therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
Keywords
Patients
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with metastatic cancer
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Blood samples
Primary Outcome Measure Information:
Title
Measurement and characterization of CEC and CEP and circulaing DNA rate using flow cytometry
Description
Measurement and characterization of initial CEC and CEP circulaing DNA and their evolution under treatment
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with metastatic solid tumor
Age> 18 years
Signed consent
Exclusion Criteria:
Patients with diseases associated with vascular lesions known.
Patients protected by law, in accordance with Articles L1121-5 to L1121-8 of the Code of Public Health.
Mental pathology that can interfere with the proper conduct of the study.
Refusal of consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Charles Soria, MD-PhD
Phone
0142114291
Ext
+33
Email
soria@gustaveroussy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Charles Soria, MD-PhD
Organizational Affiliation
Gustave Roussy Cancer Campus
Official's Role
Study Chair
Facility Information:
Facility Name
Gustave Roussy Cancer Campus Grand Paris
City
Villejuif
State/Province
Val de Marne
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Charles Soria, MD-PhD
Phone
0142114291
Ext
+33
Email
soria@gustaveroussy.fr
12. IPD Sharing Statement
Learn more about this trial
Measurement and Characterization of Circulating Endothelial Cells or Circulating Tumor Cells or Circulating DNA in Adult Patients With Metastatic Cancer
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