Early Diagnosis of High-grade Serous Epithelial Ovarian Cancer Through the Analysis of DNA Derived From Pap Test Smear.
Recruiting now · Not applicable
Conditions studied: Germline Mutations
In brief
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.
Key facts
- Study ID
- NCT07556562
- Run by
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- People needed
- 260
- Starts
- 2024-09-09
- Expected to finish
- 2027-02-28
- Last updated by the study team
- 2026-04-29
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- Germline mutated patients unwilling to join the trial and non-compliant with trial procedures
Where it is running
- Fondazione Policlinico Universitario Agostino Gemelli, IRCCS — Roma, Roma, Italy (enrolling)
Full record on ClinicalTrials.gov
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