Theranostic Approach By Early Multigene Sequencing In Advanced Poor Prognosis Cancers

Study Overview

Theranostic Approach by Early Multigene Sequencing in Advanced Poor Prognosis Cancers

The European Society for Medical Oncology (ESMO) strongly recommends to develop multigene sequencing in the framework of molecular screening programmes, in order to improve access to innovative drugs and to accelerate clinical research in cancers. * Accordingly, this project aims to study the contribution of early systematic multigene sequencing (NGS) discussed in Molecular Tumour Board for poor prognosis cancers, with no current indication for early sequencing. * The investigators teams propose to perform a randomized study in tumours in which actionable therapeutic targets according to the ESMO ESCAT scale are known (ESCAT II/IV) especially in pancreatic ductal adenocarcinoma, hepatocellular carcinoma or triple negative breast cancer. Two approaches will be compared: a large multigenic early sequencing approach since the first line setting versus a Plan France Medecine Genomique 2025 approach since the second line setting. The frequency of really initiated therapeutic proposals according to the molecular status will be compared in each group.

Part 1 sequential multi-gene sequencing (Simple NGS), * Multi-gene DNA sequencing (43 genes panel corresponding to the most frequently targeted molecular alterations) * And if no contributive: Part 2: randomized study between two sequential approaches - Experimental arm: early Multi-gene DNA sequencing (638 genes panel) Multi-gene RNA sequencing (ARCHER panel) 1. MMR status in molecular biology 2. - Tumour Mutational Burden * Control arm: after 1st line escape, according to Plan France Medecine Genomique 2025 In the Part 2, a new biopsy could be proposed if necessary

Breast Cancer
Liver Cancer
Pancreatic Ductal Adenocarcinoma

GENETIC: Large and early multigene sequencing

2023_0285

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-04-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-25
First Submitted that Met QC Criteria 2025-04-25	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-06
First Posted (ACTUAL) 2025-05-06	Results First Posted N/A	Last Verified 2025-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Screening

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Large and early multigene sequencing	GENETIC: Large and early multigene sequencing Part 1 sequential multi-gene sequencing (Simple NGS), * Multi-gene DNA sequencing (43 genes panel corresponding to the most frequently targeted molecular alterations) * And if no contributive: Part 2: randomized study between two sequential approaches
ACTIVE_COMPARATOR: Large Sequential multigene sequencing according to Plan France Medecine Genomique 2025	GENETIC: Large and early multigene sequencing Part 1 sequential multi-gene sequencing (Simple NGS), * Multi-gene DNA sequencing (43 genes panel corresponding to the most frequently targeted molecular alterations) * And if no contributive: Part 2: randomized study between two sequential approaches

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Large and early multigene sequencing

GENETIC: Large and early multigene sequencing

Part 1 sequential multi-gene sequencing (Simple NGS), * Multi-gene DNA sequencing (43 genes panel corresponding to the most frequently targeted molecular alterations) * And if no contributive: Part 2: randomized study between two sequential approaches

ACTIVE_COMPARATOR: Large Sequential multigene sequencing according to Plan France Medecine Genomique 2025

GENETIC: Large and early multigene sequencing

Part 1 sequential multi-gene sequencing (Simple NGS), * Multi-gene DNA sequencing (43 genes panel corresponding to the most frequently targeted molecular alterations) * And if no contributive: Part 2: randomized study between two sequential approaches

Primary Outcome Measures	Measure Description	Time Frame
Frequency of patients receiving a proposal for treatment leading to effective initiation of treatment.		Within 2 years of the first Molecular Tumour Board.

Secondary Outcome Measures	Measure Description	Time Frame
1. Frequency of therapeutic proposals, whether or not leading to treatment, among patients with at least one molecular alteration found		Within 2 years of the first Molecular Tumour Board.
2. The number of potentially targetable molecular alterations found.		Within 2 years of the first Molecular Tumour Board.
The frequency of the types of potentially targetable molecular alterations found according to the ESCAT classification (ESCAT I / II / III / IV).		Within 2 years of the first Molecular Tumour Board.
4. Frequency of types of therapeutic proposals (clinical trials, off-label targeted therapies).		Within 2 years of the first Molecular Tumour Board.
Time to treatment proposal, defined as the time between the date of the first Molecular Tumour Board and the treatment proposal following the second Molecular Tumour Board.		Within 2 years of the first Molecular Tumour Board.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

- Age >18 years.
Advanced disease status ("unresectable" or "metastatic").
Patient included either at the time of diagnostic investigation or during first line of treatment.
Good general conditions, still compatible with a therapeutic proposal, WHO 0-1.
The following tumour sites, with poor prognosis and for which ESCAT II/IV treatment targets can be found according to ESMO:

pancreatic adenocarcinoma
hepatocellular carcinomas,
triple negative breast cancer.
Tumour tissue a priori available in sufficient quantity: at least one biopsy from a visceral metastatic site or surgical specimen (if available) for eligible cancers.
Patient covered by a social sercurity scheme

- General condition WHO >1 and/or nutritional status not compatible with a therapeutic proposal
Limiting systemic cardiovascular, renal, bronchopulmonary or endocrinological comorbidities with the initiation of a therapeutic proposal
Active infection or active chronic disease (diabetes, liver dysfunction, immune disease) making the patient's condition incompatible with a therapeutic proposal.
A priori unavailable, in insufficient quantity or of suboptimal quality tumour material.
Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security coverage, refusal to sign consent.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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Clinical Trial Record