Implementing Precision Medicine in cOmmunity HospiTALs

Not Applicable

Recruiting

• Conditions: Metastatic Cancer
• Interventions: Biological: biopsy liquid

• Registration Number: NCT05283044
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

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 after the first radiologic assessment after treatment start. Plasma samples obtained at baseline will be tested for a large panel of gene and MSI status using Next Generation Sequencing (NGS) (cf table). Plasma samples obtained during treatment will be tested for the concentration of circulating DNA.

Results will be discussed within a Molecular Tumor Board (MTB) with all declared centers.

Study Timeline

• Study First Submitted: 2022-03-07
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-16
• Study Start: 2022-06-29
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Primary Completion: 2024-11-15
• Study Completion: 2025-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biopsy liquid contributive	biopsy liquid	Patients presenting for whom ct DNA sequencing

Primary Outcome Measures

Name	Time	Method
Proportion of patients for whom ctDNA sequencing	24 months	The primary objective of the study will be to evaluate the impact of ctDNA sequencing on the treatment plan of cancer patients managed in satellite centers. This will be performed by estimating the proportion of patients for whom ctDNA sequencing has allowed to propose a systemic treatment that was not considered before the clinician.

Secondary Outcome Measures

Name	Time	Method
Rate of molecular screening failure	24 months
Objective Response Rate	24 months
Rate of patients presenting targetable alterations	24 months	The rate of patients presenting targetable alterations according to alterations subtypes (copy number/mutation/oncogenic fusions)
Utilization rates of molecular profiling information	24 months	The utilization rates of molecular profiling information (including utilization of information for standard regimens or clinical trials of molecularly targeted therapies)
Utilization rate of tumor mutational burden	24 months	The utilization rate of tumor mutational burden (TMB - based on new generation sequencing panels)
Relapsed time between liquid biopsy and matched therapy onset	24 months
Overall Survival of patients treated with a therapy matched to a targetable alteration and recommended by the MTB based on the ctDNA sequencing	24 months

Trial Locations

Locations (20)

Centre Hospitalier; 🇫🇷 Pau, France

Hôpital Nord-Ouest Villefranche-sur-Saône; 🇫🇷 Villefranche-sur-Saône, France

Hôpital Saint-Joseph; 🇫🇷 Paris, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

CHU de La Réunion; 🇫🇷 La Réunion, France

Hôpital de la source - CHR d'Orléans; 🇫🇷 Orléans, France

Groupement Hospitalier Diaconesses-Croix; 🇫🇷 Paris, France

Hôpitaux Privés de la Loire; 🇫🇷 Saint-Étienne, France

CH Annecy Genevois; 🇫🇷 Épagny, France

Hôpital Américain; 🇫🇷 Neuilly-sur-Seine, France

CH de la Côte Basque; 🇫🇷 Bayonne, France

Polyclinique Bordeaux Nord Aquitaine; 🇫🇷 Bordeaux, France

Clinique Saint-Jean l'ermitage; 🇫🇷 Melun, France

CH de Bligny; 🇫🇷 Bligny, France

CH Sud Francilien; 🇫🇷 Corbeil-Essonnes, France

GHM de Grenoble; 🇫🇷 Grenoble, France

Centre Eugène Marquis; 🇫🇷 Rennes, France

HIA Bégin; 🇫🇷 Saint-Mandé, France

Clinique Kuindo Magnin; 🇳🇨 Noumea, New Caledonia

CHPF; 🇵🇫 Pirae, French Polynesia