Performance Indicators and Impact on the Care Pathway of Sequencing on the SeqOIA and AURAGEN (Seqogen) Platforms for Oncology Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cancer, NGS, Tumor, RARE DISEASE. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Indicateurs de Performance et Impact Sur le Parcours de Soins du Séquençage Sur Les Plateformes Seqoia et Auragen (Seqogen) Pour Les Patients en Oncologie
Overview
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.
Detailed description
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.
Primary outcome measures
- Calculation of result turnaround time. [Time frame: 8 Weeks]
- Treatment recommendation issued following the downstream multidisciplinary meeting [Time frame: 6 months]
Secondary outcome measures (3)
- Sample Arrival Time for Analysis [Time frame: 8 weeks]
- Elapsed time from sequencing to the signing of the medical biology report by the biologist [Time frame: 8 Weeks]
- Elapsed time from sequencing to the downstream multidisciplinary meeting. [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
- 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, 2021.
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.
Exclusion criteria
- Opposition to data reuse, unvalidated upstream RCP
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 3 centers
- Centre Leon Berard — Lyon
- APHP Hôtel Dieu URC Economie de la sante /URC ECO — Paris
- HOPITAL AP-HP Cochin — Paris
Identifiers
NCT: NCT07147465 · AP-HP