Performance Indicators and Impact on the Care Pathway of Sequencing on the SeqOIA and AURAGEN (Seqogen) Platforms for Oncology Patients

NCT07147465 | Recruiting

• 1 other identifier: AP-HP
• Study Type: observational
• Target: 3,149
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer; NGS; Tumor; RARE DISEASE

Keywords

Oncology; genomic medecine; cancer; rare diseases; next-generation sequencing

Outcome Measures

Primary Outcomes (2)

• Calculation of result turnaround time.

  interval from the upstream Multidisciplinary Team (MDT) meeting to the downstream multidisciplinary meeting

  8 Weeks

• Treatment recommendation issued following the downstream multidisciplinary meeting

  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.

  6 months

Secondary Outcomes (3)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with cancer and referred for high-throughput sequencing

You may qualify if:

• 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.

You may not qualify if:

• Opposition to data reuse, unvalidated upstream RCP

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• AuraGen Aesthetics LLC: collaborator
• Centre Leon Berard: collaborator
• Laboratoire SeqOIA: collaborator
• PLAN FRANCE MÉDECINE GÉNOMIQUE 2025: collaborator

Study Sites (3)

Centre Leon Berard

Lyon, 69000, France

RECRUITING

APHP Hôtel Dieu URC Economie de la sante /URC ECO

Paris, 75004, France

ACTIVE NOT RECRUITING

HOPITAL AP-HP Cochin

Paris, 75005, France

RECRUITING

MeSH Terms

Conditions

Neoplasms; Rare Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Isabelle DURAND-ZALESKI, Professor

  Greater Paris University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-07

Locations

FR (3)