Implementing Precision Medicine in cOmmunity HospiTALs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: biopsy liquid.
- Who it may be relevant to
- Registry conditions: Metastatic Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, French Polynesia, New Caledonia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This is a prospective biomarker study that aims at demonstrating the impact of liquid biopsy to deliver better treatment for cancer patients with metastatic disease managed in the community setting
Detailed description
Patients will be selected to present a metastatic cancer (de novo or relapse after primary tumor treatment) eligible for a first line treatment (chemotherapy, immunotherapy, endocrine therapy or targeted therapy).
All tumor subtype could be enrolled in the study; metastatic prostate cancer must be resistant to castration. Triple negative breast cancer and Hormone receptor positive, Her2-negative metastatic breast cancer resistant to endocrine therapy are eligible to the study.
A plasma sample will be collected at baseline and will be tested for a large panel of gene and MSI status using Next Generation Sequencing (NGS) (cf table). Results will be discussed within a Molecular Tumor Board (MTB) with all declared centers.
Interventions
- Biological biopsy liquid
Patient performs a blood test at treatment baseline
Primary outcome measures
- Proportion of patients for whom ctDNA sequencing [Time frame: 72 months]
Secondary outcome measures (7)
- Utilization rates of molecular profiling information [Time frame: 72 months]
- Rate of molecular screening failure [Time frame: 72 months]
- Relapsed time between liquid biopsy and matched therapy onset [Time frame: 72 months]
- Rate of patients presenting targetable alterations [Time frame: 72 months]
- Utilization rate of tumor mutational burden [Time frame: 72 months]
- Objective Response Rate [Time frame: 72 months]
- Overall Survival of patients treated with a therapy matched to a targetable alteration and recommended by the MTB based on the ctDNA sequencing [Time frame: 72 months]
Eligibility criteria
Inclusion criteria
Participants are eligible to be included in the study only if they meet all of the following criteria:
- Age ≥ 18 years
- Histology: solid malignant tumor
- 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)
- Eastern Cooperative Oncology Group (ECOG) performance status < 2
- Measurable disease as per RECIST criteria
- Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code)
- 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:
- Radiological evidence of symptomatic or progressive brain metastases
- 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
- 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
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
- Minors (Age < 18 years)
- Pregnant or breast-feeding women
- Previous enrollment in the present study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 19 centers
- CH de la Côte Basque — Bayonne
- CH de Bligny — Bligny
- Polyclinique Bordeaux Nord Aquitaine — Bordeaux
- CH Sud Francilien — Corbeil-Essonnes
- CH Annecy Genevois — Épagny
- GHM de Grenoble — Grenoble
- CHU de La Réunion — La Réunion
- Clinique Saint-Jean l'ermitage — Melun
- … and 11 more centers
French Polynesia · 1 center
- CHPF — Pirae
New Caledonia · 1 center
- Clinique Kuindo Magnin — Noumea
Identifiers
NCT: NCT05283044 · 2021-A02862-39 · 2021/3331