Molecular Profiling to Improve Outcome of Patients in Cancer. A Pilot Study (MULTIPLI-0)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Delay time to send a validated exome sequencing report from sample receipt
研究概览
简要总结
Next Generation Sequencing in cancer: a feasibility study in France to assess sample circuit and to perform analyzes within a limited time.
详细描述
The first France disease genomic medicine program in the field of cancer has been retained by the 2025 Genomic Medicine France Plan. This program, called MULTIPLI encompasses two innovative personalized medicine clinical trials in soft-tissue sarcoma and colorectal carcinoma involving targeted molecules according to the tumor profile of each patient.
This 1st clinical research program aims implementing exome sequencing and RNA sequencing to determine the genomic profile and to provide a therapeutic decision for each patient. Genomic analyzes will be performed on different technical platforms: samples will be collected in each investigating center, nucleic acids extraction will be performed on two genetic platforms, Inca labeled and identified for the purpose of this study: Institut Bergonié and Hôpital Européen Georges Pompidou. CNRGH (Centre National de Recherche en Génomique Humaine) was retained for operational platform genomics and Institut Bergonie for bioinformatics data processing. Each genomic profile will be discussed within a multidisciplinary tumor board which aims at providing a therapeutic decision for each patient and to propose a targeted treatment in case of actionable molecular alteration.
The purpose of this program is to perform analysis on a set of gene, in order to provide results no more than after 6 weeks after the sample arrival on the biopathological platform. This gene panel analysis is based on the predefined list of genes that are direct targets of the drugs available in the MULTIPLI program.
Before implanting this program in a large-scale launch, it was essential to set up a pilot study in order to evaluate both sample's management between several platforms, and the time to report the results, and to verify that it was in line with the objectives set.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients
- •Disease: Advanced and/or metastatic soft-tissue sarcoma OR metastatic carcinoma
- •Patient consenting to tumor sequencing, secondary reuse of their data
- •Patient informed about this study
排除标准
- 未提供
结局指标
主要结局
Delay time to send a validated exome sequencing report from sample receipt
时间窗: an average of 6 weeks
The time delay between the date of sample receipt by the platform and the date of dispatch of a validated MTB report to physician
次要结局
- The rate of patients with signed informed consent for whom a validated exome sequencing report is available(Throughout the study period, on average of 3 months)
- The rate of patients with samples received by Platform for whom a validated exome sequencing report is available(Throughout the study period, on average of 3 months)
- Delay time to send a validated exome sequencing report from signature to informed consent by the patient(an average of 8 weeks)
- Delay time to receive sample on Platform from signature of informed consent(on average of 2 weeks)
- Delay time to receipt nucleic acids on CNRGH from samples receipt on platform(on average of 1 week)
- The rate of patients with nucleic acids received on CNRGH for whom all sequencing files have been qualified by bioinformatics platform(Throughout the study period, on average of 3 months)
- The rate of patients with samples received on platform for whom these samples have been qualified in first step by platform and nucleic acids have been received by CNRGH(Throughout the study period, on average of 3 months)
- Delay time to receive bioinformatics analysis for interpretation from availability of all sequencing files(on average of 1 week)
- The rate of patients with sequencing files received by bioinformatic Platform for whom analysis have been transmitted for interpretation(Throughout the study period, on average of 3 months)
- The rate of patients with bioinformatic analysis available for interpretation for whom results has been discussed by MTB(Throughout the study period, on average of 3 months)
- The rate of patients with samples sending date completed on electronic case for whom samples have been received by platform(Throughout the study period, on average of 3 months)
- The rate of patients with samples received on platform for whom these samples have been qualified in first and second step by Platform and nucleic acids have been received by CNRGH(Throughout the study period, on average of 3 months)
- The rate of patients with sequencing files received by bioinformatic Platform for whom these files have been qualified for analysis(Throughout the study period, on average of 3 months)
- The rate of patients with signed informed consent for whom samples have been received by platform(Throughout the study period, on average of 3 months)
- The rate of patients with samples received on Platform for whom these samples have been qualified in second step by platform and nucleic acids have been received by CNRGH(Throughout the study period, on average of 3 months)
- Delay time to receive all sequencing files from nucleic acids receipt on CNRGH(on average of 3 weeks)
- The rate of patients with nucleic acids received on CNRGH for whom sequencing have been qualified by CNRGH(Throughout the study period, on average of 3 months)
- Delay time to send a validated exome sequencing report from availability of bioinformatic analysis(on average of 1 week)
- The rate of patients with bioinformatic analysis available for interpretation for whom biological interpretation has been performed(Throughout the study period, on average of 3 months)