NCT07556562 Early Diagnosis of High-grade Serous Epithelial Ovarian Cancer Through the Analysis of DNA Derived From Pap Test Smear.
| NCT ID | NCT07556562 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Germline Mutations |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2024-09-09 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 260 participants in total. It began in 2024-09-09 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Ovarian cancer is the leading cause of death among gynecological malignancies. No screening test is available for this tumor. Serous Tubal Intraepithelial Carcinoma (STIC) is the precursor lesion of the high grade serous ovarian cancer (HGSOC). Preliminary data suggest that tumor cells from STIC shed into the luminal space to reach the cervix and identical molecular alterations can be identified in the STIC and pap smears taken several years before the diagnosis. Early diagnosis could be achieved by detecting tumor components in cervical smears. This prospective/retrospective project plans to enroll high risk, germline mutated women submitted to risk reducing annessiectomy to compare the concordance of molecular alterations between tubal specimens and DNA from Pap test in order to validate a possible screening test with potential impact in reducing cancer mortality. Moreover, the evaluation of the influence of tumor micro environment in the progression from STIC to HGSOC will be studied.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07556562 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Germline Mutations. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07556562 currently recruiting?
Yes, NCT07556562 is actively recruiting participants. Contact the research team at camilla.nero@policlinicogemelli.it for enrollment information.
Where is the NCT07556562 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT07556562 clinical trial?
NCT07556562 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 260 participants.