NCT02666612

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

15 years

First QC Date

August 12, 2015

Last Update Submit

January 25, 2017

Conditions

Metastatic Cancer

Keywords

Patients

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 2 years

Study Arms (1)

Patients with metastatic cancer

OTHER
Procedure: Blood samples

Interventions

Blood samplesPROCEDURE
Patients with metastatic cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with metastatic solid tumor
  • Age\> 18 years
  • Signed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val de Marne, 94805, France

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jean Charles Soria, MD-PhD

    Gustave Roussy Cancer Campus

    STUDY CHAIR

Central Study Contacts

Jean Charles Soria, MD-PhD

CONTACT

0142114291soria@gustaveroussy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2015

First Posted

January 28, 2016

Study Start

August 1, 2008

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

FR(1)