Clinical trialNo phase (not a drug trial)Not yet recruiting
Enumeration and Functional Analysis of Circulating Tumor Cells for Homologous Recombination: a Prospective Single-center Study on Advanced/Metastatic Solid Tumors
- Outcome
- Ongoing
- Phase
- No phase (not a drug trial)
- Status
- Not yet recruiting
- Study type
- Interventional
- Start
- May 2026
- Expected end
- May 2028
- Enrollment
- 300 participants
- Sites
- 0
- Primary outcomes
- 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
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 29 April 2026
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Brief summary public domain (ClinicalTrials.gov)
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