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Enumeration and Functional Analysis of Circulating Tumor Cells for Homologous Recombination: a Prospective Single-center Study on Advanced/Metastatic Solid Tumors
Sponsor: Centre Leon Berard
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-05
Completion Date
2028-05
Last Updated
2026-04-29
Healthy Volunteers
No
Interventions
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
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.