Condition: Germline Mutations · Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.
This description comes directly from the study's public registry record.
NERO CAMILLA, MD · 0630157971 · camilla.nero@policlinicogemelli.it
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| Fondazione Policlinico Universitario Agostino Gemelli, IRCCS | Roma, Roma, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07556562