Early detection of high-grade serous ovarian cancer using DNA from Pap smear samples
Official title: Early Diagnosis of High-grade Serous Epithelial Ovarian Cancer Through the Analysis of DNA Derived From Pap Test Smear.
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07556562 · Data updated 2026-11-12
This project will test whether DNA from Pap smears can detect early signs of high-grade serous ovarian cancer in women with inherited (germline) mutations who are having risk-reducing fallopian tube or ovary surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 260 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, Roma) |
| Status | Recruiting |
| Started | September 9, 2024 |
| Main results expected | August 30, 2026 |
| Study ends | February 28, 2027 |
| Registry record updated | April 29, 2026 |
| Trial ID | NCT07556562 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are women with documented germline mutations who are candidates for prophylactic risk-reducing salpingo-oophorectomy or salpingectomy and can give informed consent.
✕Probably not a fit
Women without germline mutations, those not undergoing prophylactic surgery, or whose lesions do not shed detectable DNA to the cervix are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective and retrospective project enrolls women with germline cancer-predisposing mutations who are undergoing risk-reducing salpingo-oophorectomy or salpingectomy. Researchers will compare molecular alterations found in fallopian tube specimens, including Serous Tubal Intraepithelial Carcinoma (STIC), with DNA recovered from prior or concurrent Pap test smears to measure concordance. The goal is to validate whether tumor-derived DNA shed to the cervix can serve as a reliable early detection signal. The study will also examine how the tumor microenvironment may influence progression from STIC to high-grade serous ovarian cancer.
Why it matters
Potential benefit: If successful, this approach could enable earlier detection of high-grade serous ovarian cancer using routine Pap smears, potentially reducing cancer deaths.
How similar studies have gone: Preliminary data show identical molecular alterations in STIC lesions and Pap smears years before diagnosis, but large-scale clinical validation has not yet been completed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with germline mutations candidate to prophylactic surgery RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy) * Able and willing to sign informed consent Exclusion Criteria: * Germline mutated patients unwilling to join the trial and non-compliant with trial procedures
Where it's running
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Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
Roma, Roma, Italy Recruiting
Study contacts
- Study coordinator: Nero Camilla, Md
- Email: camilla.nero@policlinicogemelli.it
- Phone: 0630157971
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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.