RecruitingNot ApplicableNCT07556562

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

Enrollment

260 participants

Start Date

Sep 9, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria2

  • 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 Criteria1

  • Germline mutated patients unwilling to join the trial and non-compliant with trial procedures

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURERRSO (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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07556562


Related Trials