Theranostic Approach by Early Multigene Sequencing in Advanced Poor Prognosis Cancers

Sponsor
University Hospital, Lille
Study ID
NCT06958224
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Large and early multigene sequencing — GENETIC
    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

Study Details

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.

Key Dates

First listed
May 6, 2025
Start date
Apr 10, 2026
Status verified
Apr 2025
Primary completion
Nov 10, 2028
Completion
Jan 9, 2029

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Large and early multigene sequencing
  • Active Comparator: Large Sequential multigene sequencing according to Plan France Medecine Genomique 2025

Primary Outcome Measure

Frequency of patients receiving a proposal for treatment leading to effective initiation of treatment. [ Time Frame: Within 2 years of the first Molecular Tumour Board. ]

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