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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

260 Participants
are divided into 1 treatment group