Enumeration and Functional Analysis of Circulating Tumor Cells for Homologous Recombination: a Prospective Single-center Study on Advanced/Metastatic Solid Tumors
E-FACTOR
1 other identifier
interventional
300
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started May 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2026
CompletedFirst Posted
Study publicly available on registry
April 29, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
April 29, 2026
April 1, 2026
2 years
April 15, 2026
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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 Outcomes (3)
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
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
Study Arms (1)
Advanced/metastatic cancer eligible to PARP inhibitor
EXPERIMENTALInterventions
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
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie LAURENT, Dr
Centre Leon Berard
Central Study Contacts
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
April 15, 2026
First Posted
April 29, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
April 29, 2026
Record last verified: 2026-04