Performance Indicators and Impact on the Care Pathway of... | NCT07147465

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

NCT07147465

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Recruiting

Last Update Posted

Aug 29, 2025Actual

Enrollment

3,149Estimated

Phase

Not provided

Conditions

Cancer
NGS
Tumor
RARE DISEASE

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2025Actual

Primary Completion Date

Jul 31, 2026Estimated

Completion Date

Sep 30, 2026Estimated

First Submitted Date

Aug 22, 2025

First Submission Date that Met QC Criteria

Aug 22, 2025

First Posted Date

Aug 29, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2025

Last Update Posted Date

Aug 29, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Collaborators

Name	Class
AuraGen Aesthetics LLC	INDUSTRY
Centre Leon Berard	OTHER
Laboratoire SeqOIA	UNKNOWN
PLAN FRANCE MÉDECINE GÉNOMIQUE 2025

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,149Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Sample Arrival Time for Analysis	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	8 weeks
Elapsed time from sequencing to the signing of the medical biology report by the biologist

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients diagnosed with cancer and referred for high-throughput sequencing

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Isabelle DURAND-ZALESKI, Professor	Greater Paris University Hospitals	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Leon Berard	Recruiting	Lyon		69000	France

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D035583	Rare Diseases

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided