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NCT Number: NCT07555600

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

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

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Key information

Conditions

Breast Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood sampling

Procedure

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

Procedure

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.

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

    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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Elise CUCHET

CONTACT

+330469856477

Julie MOUILLAUX

CONTACT

[email protected]

+330426556824

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Acronym: E-FACTOR

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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