Early Diagnosis of High-grade Serous Epithelial Ovarian Cancer Through the Analysis of DNA Derived From Pap Test Smear.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy).
- Who it may be relevant to
- Registry conditions: Germline Mutations. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy)
Patients with germline mutations underwent RRSO (risk-reducing salpingo- oophorectomy) or RRS (risk-reducing salpingectomy)
Primary outcome measures
- NGS-Based Detection of Tubal Precancerous Lesions Using Pap Test DNA [Time frame: 1 year]
Secondary outcome measures (1)
- Tumor Microenvironment in STIC-to-HGSOC Progression [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Germline mutated patients unwilling to join the trial and non-compliant with trial procedures
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario Agostino Gemelli, IRCCS — Roma
Identifiers
NCT: NCT07556562 · 6899