Molecular Profiling to Improve Outcome of Patients in Cancer. A Pilot Study (MULTIPLI-0)

Institut National de la Santé Et de la Recherche Médicale, France

Status: Completed

Conditions: Colorectal Carcinoma; Soft Tissue Sarcoma

Treatments: Genetic: Next Generation Sequencing (NGS): exome, RNA seq

Study type: Observational

Funder types: Other

Identifiers

NCT03546127

C17-11 MULTIPLI

Details and patient eligibility

About

Next Generation Sequencing in cancer: a feasibility study in France to assess sample circuit and to perform analyzes within a limited time.

Full description

The first France disease genomic medicine program in the field of cancer has been retained by the 2025 Genomic Medicine France Plan. This program, called MULTIPLI encompasses two innovative personalized medicine clinical trials in soft-tissue sarcoma and colorectal carcinoma involving targeted molecules according to the tumor profile of each patient.

This 1st clinical research program aims implementing exome sequencing and RNA sequencing to determine the genomic profile and to provide a therapeutic decision for each patient. Genomic analyzes will be performed on different technical platforms: samples will be collected in each investigating center, nucleic acids extraction will be performed on two genetic platforms, Inca labeled and identified for the purpose of this study: Institut Bergonié and Hôpital Européen Georges Pompidou. CNRGH (Centre National de Recherche en Génomique Humaine) was retained for operational platform genomics and Institut Bergonie for bioinformatics data processing. Each genomic profile will be discussed within a multidisciplinary tumor board which aims at providing a therapeutic decision for each patient and to propose a targeted treatment in case of actionable molecular alteration.

The purpose of this program is to perform analysis on a set of gene, in order to provide results no more than after 6 weeks after the sample arrival on the biopathological platform. This gene panel analysis is based on the predefined list of genes that are direct targets of the drugs available in the MULTIPLI program.

Before implanting this program in a large-scale launch, it was essential to set up a pilot study in order to evaluate both sample's management between several platforms, and the time to report the results, and to verify that it was in line with the objectives set.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients
• Disease: Advanced and/or metastatic soft-tissue sarcoma OR metastatic carcinoma
• Patient consenting to tumor sequencing, secondary reuse of their data
• Patient informed about this study

Exclusion criteria

• N/A

Trial design

24 participants in 2 patient groups

STS

Description:

Patients with advanced/metastatic soft-tissue sarcoma

Treatment:

Genetic: Next Generation Sequencing (NGS): exome, RNA seq

CCR

Description:

Patients with metastatic colorectal carcinoma

Treatment:

Genetic: Next Generation Sequencing (NGS): exome, RNA seq