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
This trial accepts healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy)
Procedure/SurgeryPatients with germline mutations underwent RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy)
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Tumor Microenvironment in STIC-to-HGSOC Progression
To define the role of tumor microenvironment (TME) in patho-oncogenic process of the neoplastic transformations from STIC to HGSOC.
Sponsors and contacts
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