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

NCT07556562 | Recruiting DMC

• 1 other identifier: 6899
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Germline Mutations

Outcome Measures

Primary Outcomes (1)

• NGS-Based Detection of Tubal Precancerous Lesions Using Pap Test DNA

  To assess the concordance between the evidence of precancerous/cancerous tubal lesions and the results of NGS analysis in pDNA derived from Pap test smears longitudinally collected before prophylactic surgery. This aim would assess whether large genomic aberrations in pDNA are a predictive biomarker for the presence of STIC or tubal precancerous lesions and could be used for early detection of HGSOC.

  1 year

Secondary Outcomes (1)

• Tumor Microenvironment in STIC-to-HGSOC Progression

  1 year

Study Arms (1)

Risk-Reducing Salpingo-Oophorectomy or Salpingectomy in Patients with Germline Mutations

OTHER

Patients with germline mutations candidate to prophylactic surgery RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy)

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

Interventions

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

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

Risk-Reducing Salpingo-Oophorectomy or Salpingectomy in Patients with Germline Mutations

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Roma, Roma, 00186, Italy

RECRUITING

Central Study Contacts

NERO CAMILLA, MD

CONTACT

0630157971; camilla.nero@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 29, 2026
• Study Start: September 9, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

IT (1)