Condition category
Cancer
Date applied
12/06/2014
Date assigned
12/06/2014
Last edited
12/11/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Mrs Linsey Nelson

ORCID ID

Contact details

Central Manchester & Manchester Children's Hospital NHS Trust
St. Marys Hospital
Hathersage Road
Manchester
M13 0JH
United Kingdom
linsey.nelson@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16746

Study information

Scientific title

Predicting response to progestins for the treatment of endometrial hyperplasia and endometrioid adenocarcinoma of the endometrium

Acronym

MIRENA

Study hypothesis

This study aims to determine how microscopic changes in the tissue or blood of patients with endometrial hyperplasia or cancer (endometrial cancer biomarkers) change with progestin treatment and whether certain biomarkers can predict response.

On 12/11/2014 the public title was changed from 'Progestins for endometrial hyperplasia and cancer' to 'MIrena coil to Reduce Endometrial Neoplastic Abnormalities' and the acronym 'MIRENA' was added.

Ethics approval

NRES committee North West Haydock; 07/03/2014; 14/NW/0056

Study design

Non-randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Cancer; Subtopic: Gynaecological Cancer; Disease: Uterus/Endometrium

Intervention

A detailed gynaecological history, including parity, menstrual abnormalities, hormonal and contraceptive use will be taken when recruited. Weight, BMI, age and menopausal status will be assessed. Women with grade 1 stage 1a endometrial cancer on imaging or atypical endometrial hyperplasia will be treated with a Mirena coil or oral high dose progestins where hysterectomy is not recommended by the Gynaecological Oncology Specialist Multidisciplinary Team (due to surgical or anaesthetic risk, for example in a severely obese woman, or for fertility sparing reasons). Endometrial biopsies and blood samples will be taken at baseline and every 3 months, or more frequently if clinically indicated, during follow up or during surgery, up to a total duration of 12 months. Predictive biomarkers of clinical responsiveness to progestin treatment will be identified using pre-treatment blood and biopsy samples.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Ki-67 and progesterone receptor status; Timepoint(s): At approximately 3 monthly intervals (for up to a total of 12 months)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

16/06/2014

Overall trial end date

14/06/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 or more
2. Attending the gynaecological outpatient clinic at St Mary’s Hospital
3. Biopsy-proven well differentiated endometrioid adenocarcinoma of the endometrium (EC) with no myometrial invasion and/or endometrial hyperplasia (EH)
4. Clinical decision to treat EH or EC with progestins
5. Written, informed consent to take part in the study; Target Gender: Female

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 30; UK Sample Size: 30

Participant exclusion criteria

1. Non endometrioid or mixed histology or concerning histological features
2. Myometrial invasion on imaging
3. Progestin therapy contraindicated
4. Unable to sample endometrium pre/post progestin therapy

Recruitment start date

16/06/2014

Recruitment end date

14/06/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Central Manchester & Manchester Children's Hospital NHS Trust
Manchester
M13 0JH
United Kingdom

Sponsor information

Organisation

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

Sponsor details

St Mary's Hospital
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute of Health Research (NIHR) (UK)

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