CancerSONCONCT07147465
Performance Indicators and Impact on the Care Pathway of Sequencing on the SeqOIA and AURAGEN (Seqogen) Platforms for Oncology Patients
An observational study of Cancer and NGS, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- How many people
- 3,149 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Jul 2025to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with cancer and referred for high-throughput sequencing
Who may be able to join
- 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.
Who cannot join
- Opposition to data reuse, unvalidated upstream RCP
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 2 recruiting
- Recruiting
Centre Leon Berard
Lyon, 69000
PIERRE DR SAINTIGNY, DR, 04 78 78 28 67, Pierre.SAINTIGNY@lyon.unicancer.fr
- Active, not recruiting
APHP Hôtel Dieu URC Economie de la sante /URC ECO
Paris, 75004
- Recruiting
HOPITAL AP-HP Cochin
Paris, 75005
Camille Pr TLEMSANI, PUPH, 01 58 41 14 54, camille.tlemsani@aphp.fr
About this study
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
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.
Read the 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.
- Conditions
- Cancer, NGS, Tumor, RARE DISEASE
- Keywords
- Oncology, genomic medecine, cancer, rare diseases, next-generation sequencing
- Medical subject headings
- Neoplasms, Rare Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculation of result turnaround time.
interval from the upstream Multidisciplinary Team (MDT) meeting to the downstream multidisciplinary meeting
Measured: 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.
Measured: 6 months
Secondary outcomes (3)
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
Measured: 8 weeks
Elapsed time from sequencing to the signing of the medical biology report by the biologist
Delay between the date of sequencing and the date the medical biology report is validated by the biologist.
Measured: 8 Weeks
Elapsed time from sequencing to the downstream multidisciplinary meeting.
Delay between the sequencing date and the downstream multidisciplinary meeting
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Jul 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 3,149 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- AuraGen Aesthetics LLC, Centre Leon Berard, Laboratoire SeqOIA, PLAN FRANCE MÉDECINE GÉNOMIQUE 2025
- Responsible party
- Sponsor
- Investigators
- Isabelle DURAND-ZALESKI, Professor, Principal investigator, Greater Paris University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147465
- Sponsor's protocol ID
- AP-HP
- Acronym
- SONCO
- Status last verified
- Jul 2025
- First submitted
- 22 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07147465
- Acronym / sponsor ID
- SONCO / AP-HP
- Conditions
- Cancer, NGS, Tumor, RARE DISEASE
- Keywords
- Oncology, genomic medecine, cancer, rare diseases, next-generation sequencing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,149 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- AuraGen Aesthetics LLC, Centre Leon Berard, Laboratoire SeqOIA, PLAN FRANCE MÉDECINE GÉNOMIQUE 2025
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with cancer and referred for high-throughput sequencing
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Opposition to data reuse, unvalidated upstream RCP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Calculation of result turnaround time.
Time frame: 8 Weeks
interval from the upstream Multidisciplinary Team (MDT) meeting to the downstream multidisciplinary meeting
Treatment recommendation issued following the downstream multidisciplinary meeting
Time frame: 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabelle DURAND-ZALESKI, Professor principal investigator
Greater Paris University Hospitals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and NGS, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculation of result turnaround time. (time frame: 8 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.