Using liquid biopsy to improve cancer treatment in community hospitals
Implementing Precision Medicine in cOmmunity HospiTALs
This study is testing if using a simple blood test can help doctors make better treatment choices for people with advanced cancer at community hospitals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 21 sites (Bayonne and 20 other locations) |
| Trial ID | NCT05283044 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with locally advanced or metastatic solid tumors, including specific types of breast and prostate cancers.
Not a fit: Patients with symptomatic or progressive brain metastases or those with other malignancies within the last five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment options for patients with metastatic cancer.
How similar studies have performed: Other studies utilizing liquid biopsy for cancer treatment have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bayonne and 20 other locations
- CH de la Côte Basque — Bayonne, France (Recruiting)
- CH de Bligny — Bligny, France (Recruiting)
- Polyclinique Bordeaux Nord Aquitaine — Bordeaux, France (Active_not_recruiting)
- CH Sud Francilien — Corbeil-Essonnes, France (Recruiting)
- CH Annecy Genevois — Épagny, France (Active_not_recruiting)
- GHM de Grenoble — Grenoble, France (Active_not_recruiting)
- CHU de La Réunion — La Réunion, France (Recruiting)
- Clinique Saint-Jean l'ermitage — Melun, France (Active_not_recruiting)
- Hôpital Américain — Neuilly-sur-Seine, France (Recruiting)
- Hôpital de la source - CHR d'Orléans — Orléans, France (Recruiting)
- Hôpital Saint-Joseph — Paris, France (Recruiting)
- Institut Mutualiste Montsouris — Paris, France (Recruiting)
- Groupement Hospitalier Diaconesses-Croix — Paris, France (Recruiting)
- Centre Hospitalier — Pau, France (Recruiting)
- Centre Eugène Marquis — Rennes, France (Recruiting)
- Hôpitaux Privés de la Loire — Saint-Etienne, France (Active_not_recruiting)
- HIA Bégin — Saint-Mandé, France (Recruiting)
- Hôpital Foch — Suresnes, France (Not_yet_recruiting)
- Hôpital Nord-Ouest Villefranche-sur-Saône — Villefranche-sur-Saône, France (Recruiting)
- Chpf — Pirae, French Polynesia (Active_not_recruiting)
- Clinique Kuindo Magnin — Noumea, New Caledonia (Active_not_recruiting)
Study contacts
- Study coordinator: Benjamin Verret, MD
- Email: Benjamin.verret@gustaveroussy.fr
- Phone: +33 (0)1 42 11 42 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.