Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Large and early multigene sequencing | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Large and early multigene sequencing
- interventionNames
- Genetic: Large and early multigene sequencing
- type
- ACTIVE_COMPARATOR
- label
- Large Sequential multigene sequencing according to Plan France Medecine Genomique 2025
- interventionNames
- Genetic: Large and early multigene sequencing
Primary outcomes (1)
- measure
- Frequency of patients receiving a proposal for treatment leading to effective initiation of treatment.
- timeFrame
- Within 2 years of the first Molecular Tumour Board.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* \- 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
Exclusion Criteria:
* \- 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.References
Publications (0)
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