Ovarian Cancer Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Italy
Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
RECRUITING
Roma
Contact Information
Primary
NERO CAMILLA, MD
camilla.nero@policlinicogemelli.it
0630157971
Time Frame
Start Date: 2024-09-09
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 260
Treatments
Other: Risk-Reducing Salpingo-Oophorectomy or Salpingectomy in Patients with Germline Mutations
Patients with germline mutations candidate to prophylactic surgery RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy)
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov