NCT02220556

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

December 1, 2010

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

7.5 years

First QC Date

August 8, 2014

Last Update Submit

August 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • CTC, CEC or ctDNA incidence

    number of CTC or CEC in 7.5ml of blood

    3 years

Secondary Outcomes (2)

  • CTC and CEC molecular characterization

    3 years

  • Circulating tumor DNA (ctDNA) detection and quantification

    3 years

Interventions

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institut Curie

Paris, 75005, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Institut Curie

Saint-Cloud, 92210, France

Location

Related Publications (2)

  • 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.

    PMID: 30054279BACKGROUND
  • 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.

    PMID: 30901876BACKGROUND

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jean-Yves Pierga, Prof.

    Institut Curie

    PRINCIPAL INVESTIGATOR
  • François-Clément Bidard, MD, PhD

    Institut Curie

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

August 8, 2014

First Posted

August 20, 2014

Study Start

December 1, 2010

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

August 8, 2025

Record last verified: 2025-08

Locations