Condition category
Cancer
Date applied
10/03/2014
Date assigned
23/04/2014
Last edited
23/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Endometrial cancer, or cancer of the lining of the womb, has become the most common cancer of the reproductive tract in British women. Obese women are at increased risk of the disease and are also more likely to die from it. The recent obesity epidemic means that more women than ever before are developing the disease. Endometrial cancer can usually be cured by surgery but for obese or elderly women, surgery may be dangerous. It also renders a woman infertile. There is an urgent need to develop preventative strategies for an increasingly obese female population. Understanding more about the mechanisms linking obesity and endometrial cancer will help the development of these.
Bariatric surgery (reduction of stomach capacity by e.g. gastric banding) results in rapid weight loss: 10-15% excess body weight will be lost in six weeks with resolution of body mass index (BMI) to within the normal/overweight range (BMI 25-30) by 12 months. Non-surgical weight loss management can be effective but produces much slower results. Looking at the changes in the endometrium following weight loss may help us understand what causes endometrial cancer to develop and from there we can then look at what can be done to stop endometrial cancer developing.

Who can participate?
We will recruit around 100-150 morbidly obese (BMI>40) women aged 18 years or more who have been offered bariatric surgery or a non-surgical weight loss programme.

What does the study involve?
Both groups of women will have blood samples and a sample of the lining of the womb (endometrial biopsy) taken at recruitment. The women will then undergo surgery or follow their weight loss programme. All women will attend a follow up appointment 2 and 12 months later when a further blood sample and sample of the lining of the womb will be taken. Women will be asked to report their general health while in the study by filling out a questionnaire. They will also be asked about their quality of life before and after weight loss.

What are the possible benefits and risks of participating?
There will be no direct benefit to many of those taking part, but there should be benefits for future women with endometrial cancer because this study will help us investigate why endometrial cancer develops. Some patients with underlying endometrial pathology will be identified by taking part in the study, and for these women, further investigations and treatment may be necessary.

Where is the study run from?
Patients will be recruited from the Obesity Clinic at Salford Royal Hospital and followed up at St Mary’s Hospital in Manchester (UK).

When is study starting and how long is it expected to run for?
The study started April 2012 and is likely to complete April 2016.

Who is funding the study?
The research fellow salaries are funded by Central Manchester University Hospitals NHS Foundation Trust and the project costs are funded by NIHR (UK).

Who is the main contact?
Dr Emma Crosbie
emma.crosbie@manchester.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emma Crosbie

ORCID ID

Contact details

Institute of Cancer Sciences
St. Mary's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 4 - 02.08.13

Study information

Scientific title

The impact of obesity and weight loss on the endometrium: a prospective cohort study

Acronym

Study hypothesis

Obesity and weight loss affect endometrial proliferation

Ethics approval

NRES Committee North West - Lancaster, 23/01/2012, ref.12/NW/0050

Study design

Prospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Endometrial cancer

Intervention

Medical history, height and weight (to calculate BMI) hip and waist measurements a blood sample and an endometrial biopsy will be taken at the baseline clinic visit. At 6 weeks and 9-12 months post-surgery or post-initiation of medical treatment these will all be repeated. A general health questionnaire will be completed at the baseline clinic visit and at 12 months follow up.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Ki67 expression by the endometrium (a marker of proliferation) measured at baseline and post weight loss (endometrial biopsy).

Secondary outcome measures

Endometrial markers, physiological markers and changes in menstrual function and mental wellbeing measured at baseline and post weight loss (blood sample and questionnaire).

Overall trial start date

01/04/2012

Overall trial end date

01/04/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female aged 18 years or more
2. Undergoing bariatric surgery or commencing medical weight management therapy
3. Written informed consent to participate in the study

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

150

Participant exclusion criteria

1. Previous hysterectomy
2. Intrauterine device (IUD) or levonorgestrel intrauterine system (LNG-IUS) in situ
3. Previous endometrial ablation
4. Treatment with tamoxifen
5. Pregnancy

Recruitment start date

01/04/2012

Recruitment end date

01/04/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Cancer Sciences
Manchester
M13 9WL
United Kingdom

Sponsor information

Organisation

Central Manchester University Hospitals NHS Foundation Trust (CMFT) (UK)

Sponsor details

Oxford Road
Manchester
M13 9WL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Central Manchester University Hospitals NHS Foundation Trust (research fellow salaries) and NIHR (project costs).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes