Routine shallow-coverage Whole Genome Sequencing of Cervical Smears to See if Ovarian Cancer is Found Earlier
Official title: Routine Shallow-coverage Whole Genome Sequencing Testing of Liquid-based Cervical Smears for the Early Diagnosis of Ovarian Cancer
Run by Institut Claudius Regaud · NCT07821879 · Data updated 2026-11-12
Researchers test whether analyzing DNA from cervical smears with shallow whole-genome sequencing can help detect high-grade serous ovarian cancer early in patients undergoing treatment for this cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | Institut Claudius Regaud Academic / other |
| Locations | 1 site (Toulouse) |
| Status | Recruiting |
| Started | January 5, 2025 |
| Main results expected | January 4, 2027 |
| Study ends | January 4, 2027 |
| Registry record updated | September 16, 2026 |
| Trial ID | NCT07821879 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Patients with high-grade serous ovarian carcinoma at the Institut Claudius Regaud who are planned for initial diagnostic or cytoreductive surgery.
✕Probably not a fit
Patients without detectable cervical TP53/genomic instability signals or who do not have concurrent cervical pathology may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects tumour and healthy tissue samples from patients with high-grade serous ovarian cancer who are scheduled for initial surgery. A liquid-based cervical smear is taken as part of routine care to screen for concomitant cervical cancer, and DNA is analyzed for genomic instability using whole-genome sequencing. The study aims to see if tumor-derived signals in cervical samples can indicate ovarian cancer origin noninvasively. Analyses include quantifying tumor material, DNA extraction and sequencing, and standard histopathology for confirmation. Interventions are not tested; the study observes and analyzes diagnostic material from the care pathway.
Why it matters
Potential benefit: If successful, this approach could lead to a noninvasive method for earlier detection or better understanding of tumor biology in HGSOC.
How similar studies have gone: Previous work has suggested TP53 mutations and genomic instability can be detected in cervical samples, supporting feasibility, though this specific WGS-based approach is exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients : * With high-grade serous ovarian carcinoma treated at the IUCT-O * For whom initial surgery (diagnostic or cytoreductive) is planned Exclusion Criteria: Patients with : * Concurrent endometrial or cervical cancer * History of cancer within the last two years * History of gynaecological cancer * History of salpingectomy, hysterectomy or trachelectomy (removal of the cervix)
Where it's running
-
Institut Claudius Regaud
Toulouse, France Recruiting
Study contacts
- Study coordinator: Giulio Ricotta, Dr
- Email: ricotta.giulio@iuct-oncopole.fr
- Phone: +33(0)5 31 15 50 50
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.