Indicateurs de Performance et Impact Sur le Parcours de Soins du Séquençage Sur Les Plateformes Seqoia et Auragen (Seqogen) Pour Les Patients en Oncologie
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,149
- 试验地点
- 3
- 主要终点
- Calculation of result turnaround time.
研究概览
简要总结
As part of the French Genomic Medicine Plan 2025 (FGM), the SeqOIA and AURAGEN platforms were selected to perform high-throughput genomic sequencing.
The SONCO (Sequencing Oncology Cohort) project combines their medical and economic evaluations into a single national cohort. Its objective is to assess the impact of genomic sequencing on care pathways and treatment recommendations by collecting indicators related to quality, turnaround time, and patient information. Clinical data are gathered from molecular tumor board reports (via SPICE and HYGEN) and from hospital medical records.
This cohort is intended to support public health decision-making and help anticipate the organization of future genomic platforms.
详细描述
SONCO is an observational cohort study designed to assess the clinical and organizational impact of implementing genomic sequencing in oncology. It collects data from all patients referred to either of the two platforms AURAGEN and SeqOIA, focusing on several key indicators: turnaround times, quality of patient information, and overall quality of care.
The study incorporates: Clinical and molecular decisions from national molecular tumor boards (MTB), recorded via digital tools such as SPICE and HYGEN; Additional clinical data from patient medical records before and after sequencing, collected from the hospitals where patients are followed.
The overarching aim is to evaluate how genomic information influences patient care trajectories and treatment decisions. By analyzing these real-world data, SONCO will contribute to optimizing future genomic medicine workflows, contribute to the development of national guidelines in partnership with professional societies, and help shape public health strategies. It also plays a critical role in anticipating the organizational and resource needs for scaling up genomic services across France.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with cancer and referred for high-throughput sequencing
- •Sequencing pre-indication validated: Patients for whom the pre-indication for sequencing the genome, exome, and RNA has been validated by the upstream RCP (Multidisciplinary Tumor Board) since January 1,
- •Consent for data reuse: Patients who have agreed to the reuse of their medical and genomic data for research purposes and have not opposed this use.
排除标准
- •Opposition to data reuse, unvalidated upstream RCP
结局指标
主要结局
Calculation of result turnaround time.
时间窗: 8 Weeks
interval from the upstream Multidisciplinary Team (MDT) meeting to the downstream multidisciplinary meeting
Treatment recommendation issued following the downstream multidisciplinary meeting
时间窗: 6 months
Prescription details include the actual treatment prescribed, the patient's response to treatment, the number of therapy lines received after the initial prescription, the specific molecule prescribed, and the type of genomic alteration guiding the therapeutic choice.
次要结局
- Sample Arrival Time for Analysis(8 weeks)
- Elapsed time from sequencing to the signing of the medical biology report by the biologist(8 Weeks)
- Elapsed time from sequencing to the downstream multidisciplinary meeting.(8 weeks)