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RECRUITING
NCT07556562
NA

Early Diagnosis of High-grade Serous Epithelial Ovarian Cancer Through the Analysis of DNA Derived From Pap Test Smear.

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2024-09-09

Completion Date

2027-02-28

Last Updated

2026-04-29

Healthy Volunteers

Yes

Interventions

PROCEDURE

RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy)

Patients with germline mutations underwent RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy)

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Roma, Roma, Italy