Enumeration and Functional Analysis of Circulating Tumor Cells for Homologous Recombination: a Prospective Single-center Study on Advanced/Metastatic Solid Tumors (E-FACTOR)

April 21, 2026 updated by: Centre Leon Berard

The goal of this clinical trial is to is to evaluate whether a correlation exists between functional HR status/CTC enumeration in expanded CTCs measured before treatment initiation, and Progression Free Survival (PFS) under PARPi and/or DNA-damaging. This proof-of-concept study is a first step to confirm the hypothesis that a dual parameter approach combining (i) longitudinal monitoring of CTC enumeration and (ii) functional assessment of HR capacity in ex vivo expanded CTCs will enable accurate prediction of therapeutic response to PARPi and cytotoxic chemotherapies, particularly those involving cross-linking DNA-damaging agents such as platinum salts in 300 adult patients witch advances/metastatic Ovarian, Breast, Prostate, or Pancreatic cancer potentially eligible to PARP inhibitor treatment as standards of care at the center Léon Bérard.

The main questions it aims to answer are:

  • Correlation between functional HR status/CTC enumeration in expanded CTCs measured before treatment initiation and Progression Free Survival (PFS) under PARPi and/or DNA-damaging chemotherapy
  • Proportion of patients from whom ≥1 CTC colony can be successfully isolated and expanded ex vivo under predefined culture conditions
  • Distribution of CTC samples classified as HR-proficient vs HR-deficient based on assay-specific thresholds

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Elise CUCHET
  • Phone Number: +330469856477

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female patients ≥ 18 years at the day of signing informed consent.
  • Advanced/metastatic breast, prostate, ovarian and pancreatic cancer patients potentially eligible to PARP inhibitor treatment as monotherapy or in combination as per respective SmPC (see Appendix 1) or IB if the PARPi treatment is investigational.
  • Patients who have understood, dated, and signed the written voluntary informed consent form before undergoing any procedure specific to the protocol.
  • Patients affiliated with or benefiting from medical insurance.

Exclusion Criteria:

  • Patients with secondary malignancy with the exception of basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, localized prostate cancer, prior malignancy and no evidence of recurrence for ≥ 2 years.
  • Patients presenting a psychological, familial, geographical, or social situation that, in the investigator's judgment, could potentially prevent the signing of informed consent and/or compliance with study procedures.
  • Pregnant or breast-feeding women.
  • Patients under judicial protection (guardianship, curatorship, or legal safeguard), adults under protection in accordance with Articles L.1121-6, L.1121-8, and L.1121-8-1 of the French Public Health Code, as well asindividuals not affiliated with a social security scheme or without equivalent health coverage.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Advanced/metastatic cancer eligible to PARP inhibitor
Procedure: blood sampling
Blood samples will be collected at 4 timepoints: prior to induction chemotherapy if applicable, prior to initiation of PARPi treatment, after 1 full cycle of PARPi (28 days) and in case of progression
Procedure: Tumor sampling
Archival FFPE tumor samples from initial diagnosis, surgery, or biopsy in case of relapse/progression will be collected if available. If a biopsy is performed during the study as part of standard of care, an additional fragment will be collected for this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between functional HR status/CTC enumeration in expanded CTCs measured before treatment initiation and Progression Free Survival (PFS) under PARPi and/or DNA-damaging chemotherapy
Time Frame: Until up to 18 years follow-up of the last patient enrolled
Correlation between functional HR status/CTC enumeration in expanded CTCs measured before treatment initiation and Progression Free Survival (PFS) under PARPi and/or DNA-damaging chemotherapy
Until up to 18 years follow-up of the last patient enrolled

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients from whom ≥1 CTC colony can be successfully isolated and expanded ex vivo under predefined culture conditions
Time Frame: Until up to 18 years follow-up of the last patient enrolled
Proportion of patients from whom ≥1 CTC colony can be successfully isolated and expanded ex vivo under predefined culture conditions
Until up to 18 years follow-up of the last patient enrolled
Distribution of CTC samples classified as HR-proficient vs HR-deficient based on assay-specific thresholds
Time Frame: Until up to 18 years follow-up of the last patient enrolled
Distribution of CTC samples classified as HR-proficient vs HR-deficient based on assay-specific thresholds
Until up to 18 years follow-up of the last patient enrolled
Correlation between functional HR status/CTC enumeration with response rate (RR) and OS
Time Frame: Until up to 18 years follow-up of the last patient enrolled
Correlation between functional HR status/CTC enumeration with response rate (RR) and OS
Until up to 18 years follow-up of the last patient enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Investigators

  • Principal Investigator: Marie LAURENT, Dr, Centre Léon Bérard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-A01841-48

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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