Using liquid biopsy to improve cancer treatment in community hospitals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective biomarker study focuses on the use of liquid biopsy to enhance treatment outcomes for patients with metastatic cancer in community settings. Eligible participants include those with various tumor subtypes, specifically metastatic prostate cancer resistant to castration, triple-negative breast cancer, and hormone receptor-positive, HER2-negative metastatic breast cancer resistant to endocrine therapy. Plasma samples will be collected at baseline and after the first radiologic assessment to analyze genetic markers and circulating DNA. The findings will be reviewed by a Molecular Tumor Board to guide treatment decisions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants are eligible to be included in the study only if they meet all of the following criteria:

1. Age ≥ 18 years
2. Histology: solid malignant tumor
3. Locally advanced/unresectable and/or metastatic (for prostate cancer: castration resistant prostate cancer, for RH+/HER2- breast cancer: prior treatment with endocrine therapy plus anti-CDK4/6 inhibitor)
4. Eastern Cooperative Oncology Group (ECOG) performance status \< 2
5. Measurable disease as per RECIST criteria
6. Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code)
7. Voluntary signed and dated written informed consent prior to any study specific procedure.

Exclusion Criteria:

Participants will be excluded from the study if they meet any of the following criteria:

1. Radiological evidence of symptomatic or progressive brain metastases
2. Previous or current malignancies of others histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer
3. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol
4. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
5. Minors (Age \< 18 years)
6. Pregnant or breast-feeding women
7. Previous enrollment in the present study.

Where it's running

• CH de la Côte Basque
  Bayonne, France Recruiting
• CH de Bligny
  Bligny, France Recruiting
• CH Sud Francilien
  Corbeil-Essonnes, France Recruiting
• CHU de La Réunion
  La Réunion, France Recruiting
• Hôpital Américain
  Neuilly-sur-Seine, France Recruiting
• Hôpital de la source - CHR d'Orléans
  Orléans, France Recruiting

Study contacts

• Study coordinator: Benjamin Verret, MD
• Email: Benjamin.verret@gustaveroussy.fr
• Phone: +33 (0)1 42 11 42 11

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.