NCT06958224

Theranostic Approach by Early Multigene Sequencing in Advanced Poor Prognosis Cancers

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Breast Cancer
• Liver Cancer
• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-10
• Primary completion: 2028-11-10
• Completion: 2029-01-09
• First posted: 2025-05-06
• Last updated: 2026-02-20