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Quality of life after surgery and other options to prevent cancer of the lining of the womb (endometrial cancer)

Prevention of endometrial cancers: comparing risk-reducing strategies

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN17432105
Enrollment
750
Registered
2022-12-17
Start date
2023-06-13
Completion date
Unknown
Last updated
2024-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lynch syndrome Cancer Hereditary non-polyposis colorectal cancer (HNPCC)

Interventions

Potential participants will be contacted by their usual treating team, or via support charities such as Lynch Syndrome UK (for individuals who have previously voluntarily signed up to such mailing lis

Sponsors

Queen Mary University of London
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Female 2. Age >18 years old 3. Lynch Syndrome diagnosis - confirmed germline mutation in MLH1, MSH2, MSH6, PSM2, ECPAM 4. UK Resident

Exclusion criteria

Exclusion criteria: 1. Unwilling or unable to provide informed consent 2. Inability to understand written and verbal English

Design outcomes

Primary

MeasureTime frame
Health-related utility scores for risk-reducing hysterectomy for endometrial cancer prevention, measured using EQ-5D questionnaire at baseline

Secondary

MeasureTime frame
1. Variables predictive for risk reducing hysterectomy, measured using a customised questionnaire alongside EQ-5D at baseline 2. Separate health-related utility scores for pre and post-menopausal patients undergoing risk-reducing hysterectomy with and without ovarian conservation, measured using a customised questionnaire alongside EQ-5D at baseline 3. Endometrial cancer risk threshold for undergoing risk-reducing hysterectomy, using Markov modelling to perform cost-utility analysis, following collection of EQ-5D data. 4. Cost-effectiveness of risk-reducing hysterectomy, using Markov modelling to perform cost-utility analysis, following collection of EQ-5D data. 2. Costs will be measured using a UK public healthcare system (payers) perspective, with values derived from the literature. A lifetime horizon will be used with appropriate discounting. Cost-effectiveness will be calculated using the incremental cost-effectiveness ratio (ICER), and compared against the willingness-to-pay threshold from the UK National Institute of Health and Care Excellence of £20,000 - £30,000 per quality-adjusted life year (QALY).

Countries

England, United Kingdom

Contacts

Public ContactSamuel Oxley
s.oxley@qmul.ac.uk+44 2078828491

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026