NCT06958224尚未招募不适用
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.
University Hospital, Lille0 个研究点目标入组 360 人开始时间: 2026年4月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 360
- 主要终点
- Frequency of patients receiving a proposal for treatment leading to effective initiation of treatment.
研究概览
简要总结
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.
详细描述
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)
- MMR status in molecular biology
- - Tumour Mutational Burden
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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-
- •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
排除标准
- •- 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.
研究组 & 干预措施
Large and early multigene sequencing
Experimental
干预措施: Large and early multigene sequencing (Genetic)
Large Sequential multigene sequencing according to Plan France Medecine Genomique 2025
Active Comparator
干预措施: Large and early multigene sequencing (Genetic)
结局指标
主要结局
Frequency of patients receiving a proposal for treatment leading to effective initiation of treatment.
时间窗: Within 2 years of the first Molecular Tumour Board.
次要结局
- 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.)
研究者
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