Cancer, NGS, RARE DISEASE, Tumor
Conditions
Keywords
Oncology, genomic medecine, cancer, rare diseases, next-generation sequencing
Brief summary
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.
Interventions
None listed
Sponsors
AuraGen Aesthetics LLC
Centre Leon Berard
Laboratoire SeqOIA
PLAN FRANCE MÉDECINE GÉNOMIQUE 2025
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calculation of result turnaround time. | 8 Weeks | interval from the upstream Multidisciplinary Team (MDT) meeting to the downstream multidisciplinary meeting |
| Treatment recommendation issued following the downstream multidisciplinary meeting | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sample Arrival Time for Analysis | 8 weeks | Interval between the date of the upstream Multidisciplinary Team (MDT) meeting and the date of arrival of the tumor sample at one of the platforms for anatomical pathology prequalification/qualification |
| Elapsed time from sequencing to the signing of the medical biology report by the biologist | 8 Weeks | Delay between the date of sequencing and the date the medical biology report is validated by the biologist. |
| Elapsed time from sequencing to the downstream multidisciplinary meeting. | 8 weeks | Delay between the sequencing date and the downstream multidisciplinary meeting |
Countries
France
Outcome results
None listed