Prevention Of Endometrial Tumours (POET) - POET
- Conditions
- Endometrial cancer/tumours in women with Hereditary Non-polyposis Colorectal Cancer (HNPCC)MedDRA version: 9.1Level: LLTClassification code 10051981Term: Lynch syndrome
- Registration Number
- EUCTR2006-001815-30-GB
- Lead Sponsor
- St George's, University of London (SGUL)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Women with HNPCC, intact uterus, aged of 30-65y.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Pregnant
not HNPCC
Affected with endometrial cancer
Outside age range
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assess the efficacy of the Mirena IUS to reduce atypical endometrial hyperplasia and endometrial cancer in women with HNPCC, who have a lifetime risk of up to 60% of developing endometrial cancer.;Primary end point(s): Detection of atypical endometrial hyperplasia or cancer;Secondary Objective: Assess the patient acceptability and psychological effects of the Mirena IUS in this context . Also assess the efficacy of surveillance to detect endometrial hyperplasia and cancer using transvaginal ultrasound and endometrial biopsy, and the natural history of endometrial hyperplasia-neoplasia in women with HNPCC. Also assess the possible adverse effects of this treatment.
- Secondary Outcome Measures
Name Time Method