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 measure
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 (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 18 or more
2. Attending the gynaecological outpatient clinic at St Marys 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
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
Basic results (scientific)
Publication list