Clinical trial NCT05283044: Implementing Precision Medicine in cOmmunity HospiTALs
Official title: Implementing Precision Medicine in cOmmunity HospiTALs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Cancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2022-03-16
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Proportion of patients presenting for whom ct DNA sequencing has allowed to propose a systemic treatment that was not considered before by the clinician.
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Proportion of patients for whom ctDNA sequencing
timeFrame: 24 months
Secondary outcomes:
measure: Utilization rates of molecular profiling information
timeFrame: 24 months
measure: Rate of molecular screening failure
timeFrame: 24 months
measure: Relapsed time between liquid biopsy and matched therapy onset
timeFrame: 24 months
measure: Rate of patients presenting targetable alterations
timeFrame: 24 months
measure: Utilization rate of tumor mutational burden
timeFrame: 24 months
measure: Objective Response Rate
timeFrame: 24 months
measure: Overall Survival of patients treated with a therapy matched to a targetable alteration and recommended by the MTB based on the ctDNA sequencing
timeFrame: 24 months
Other outcomes:
Locations:
city: Bayonne
country: France
facility: CH de la Côte Basque
city: Bligny
country: France
facility: CH de Bligny
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Corbeil-Essonnes
country: France
facility: CH Sud Francilien
city: Grenoble
country: France
facility: GHM de Grenoble
city: La Réunion
country: France
facility: CHU de La Réunion
city: Melun
country: France
facility: Clinique Saint-Jean l'ermitage
city: Neuilly-sur-Seine
country: France
facility: Hôpital Américain
city: Orléans
country: France
facility: Hôpital de la source - CHR d'Orléans
city: Paris
country: France
facility: Hôpital Saint-Joseph
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: Groupement Hospitalier Diaconesses-Croix
city: Pau
country: France
facility: Centre Hospitalier
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Saint-Mandé
country: France
facility: HIA Bégin
city: Saint-Étienne
country: France
facility: Hôpitaux Privés de la Loire
city: Villefranche-sur-Saône
country: France
facility: Hôpital Nord-Ouest Villefranche-sur-Saône
city: Épagny
country: France
facility: CH Annecy Genevois
city: Pirae
country: French Polynesia
facility: CHPF
city: Noumea
country: New Caledonia
facility: Clinique Kuindo Magnin
Study officials:
References: