Non-Invasive Diagnosis of Endometrial Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometrial Cancer
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Activating variants and MSI via cytology
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The study aims to determine whether next generation sequencing and microsatellite analysis of cervical cytology is sensitive for the detection of endometrial carcinoma.
Detailed Description
Definitive diagnosis of endometrial cancer relies on endometrial biopsy, in addition to imaging. Biopsy is however invasive and often painful, and its sensitivity in only moderate. Cervical cytology could be an alternative. This is a proof-of-concept study. The investigators will carry out next generation sequencing of cervical cytology in patients with confirmed endometrial carcinoma, in order to determine whether activating variants are identified. About 15% of endometrial carcinomas are microsatellite instable (MSI). The investigators will therefore also carry out MSI analysis using MSICare in the subset of cases with MMR-deficient cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Endometrial cancer requiring hysterectomy
- •Patient covered by French social Security
- •Patient capable of giving written informed consent
Exclusion Criteria
- •Chemotherapy
Outcomes
Primary Outcomes
Activating variants and MSI via cytology
Time Frame: 16 months
proportion of cases in whom genetic activating variants and microsatellite instability are detected by cytology
Secondary Outcomes
- Comparison with the proportion of variants seen on the pathological(16 months)
- Frequency of variants(16 months)
- Number of variants(16 months)
- Comparison with the proportion of microsatellite instability detected on the pathological specimen.(16 months)
- Type of variants(16 months)