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Early detection of women at high risk of developing cancer of the lining of the womb

Predicting Risk of Endometrial Cancer: a multivariate prediction model with combination of lifestyle factors, clinical biochemistry, histological and genetic analysis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN43327977
Enrollment
164
Registered
2017-03-24
Start date
2016-10-03
Completion date
Unknown
Last updated
2018-02-12

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

Conditions

Endometrial cancer, endometrial hyperplasia, polyps and normal endometrium Cancer

Interventions

The project will involve a comprehensive analysis of endometrial hyperplasia (EH) against endometrial cancer (EC), polyps and normal samples, and compare findings with diet and lifestyle parameters as

Sponsors

Portsmouth Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women seen in Post Menopausal Clinic at Queen Alexandra Hospital 2. Ability to consent 3. Aged 40 years or over 4. Women with endometrial polyps 5. Women with prolapse awaiting surgery 6. Normal up to date smear 7. Normal endometrial sampling at screening 8. Not on prior endocrine treatment 9. No other/second cancer in the present or past;Inclusion criteria: 1. Women seen in Post Menopausal Clinic at Queen Alexandra Hospital 2. Ability to consent 3. Aged 40 years or over 4. Women with endometrial polyps 5. Women with prolapse awaiting surgery 6. Normal up to date smear 7. Normal endometrial sampling at screening 8. Not on prior endocrine treatment 9. No other/second cancer in the present or past

Exclusion criteria

Exclusion criteria: Exclusion criteria as of 21/04/2017: 1. Previous hysterectomy 2. Breast cancer and breast cancer therapy 3. Taking systemic hormone replacement therapy or endocrine treatment Original exclusion criteria: 1. Previous hysterectomy 2. Breast cancer and breast cancer therapy 3. Congenital/acquired uterine anomalies 4. Pelvic inflammatory disease, previous and active 5. Immunodeficiency or any chronic disease 6. Taking systemic hormone replacement therapy or endocrine treatment;Exclusion criteria: Exclusion criteria as of 21/04/2017: 1. Previous hysterectomy 2. Breast cancer and breast cancer therapy 3. Taking systemic hormone replacement therapy or endocrine treatment Original exclusion criteria: 1. Previous hysterectomy 2. Breast cancer and breast cancer therapy 3. Congenital/acquired uterine anomalies 4. Pelvic inflammatory disease, previous and active 5. Immunodeficiency or any chronic disease 6. Taking systemic hormone replacement therapy or endocrine treatment

Design outcomes

Primary

MeasureTime frame
Lifestyle and diet assessment score, biochemical data, histological grade and genetic data will form a multivariate model. Generated data will be used for statistical modeling, where tests will be performed to determine differences between study cases. In order to determine which combination of tested variables best predicts EC, a stepwise discriminant analysis will be used.;Lifestyle and diet assessment score, biochemical data, histological grade and genetic data will form a multivariate model. Generated data will be used for statistical modeling, where tests will be performed to determine differences between study cases. In order to determine which combination of tested variables best predicts EC, a stepwise discriminant analysis will be used.

Secondary

MeasureTime frame
Detection of differences in biochemical, histological and genetic results between studied conditions.;Detection of differences in biochemical, histological and genetic results between studied conditions.

Countries

United Kingdom

Contacts

Public ContactIolia;Iolia Akaev;Akaev

;

iolia.akaev@port.ac.uk;iolia.akaev@port.ac.uk+44 7703 772086;+44 7703 772086

Outcome results

None listed

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