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NOT YET RECRUITING
NCT06958224
NA

Theranostic Approach by Early Multigene Sequencing in Advanced Poor Prognosis Cancers

Sponsor: University Hospital, Lille

View on ClinicalTrials.gov

Summary

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.

Official title: Theranostic Approach by Early Multigene Sequencing in Advanced Poor Prognosis Cancers, Not Eligible for Initial Sequencing in Clinical Routine and Selected From the First Line in Molecular Tumour Board.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2026-04-10

Completion Date

2029-01-09

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

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 \- 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