MIrena coil to Reduce Endometrial Neoplastic Abnormalities

ISRCTN	ISRCTN31662931
DOI	https://doi.org/10.1186/ISRCTN31662931
IRAS number	148213
Secondary identifying numbers	16746, IRAS 148213

Submission date: 12/06/2014
Registration date: 12/06/2014
Last edited: 11/04/2023

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/trials/a-study-to-work-out-who-might-respond-to-hormone-treatment-for-pre-cancerous-cells-in-the-womb-and-womb-cancer-mirena-study

Contact information

Prof Emma Crosbie
Scientific

University of Manchester
Division of Cancer Sciences
School of Medical Sciences
Faculty of Biology Medicine and Health
St Mary's Hospital
Manchester
M16 9WL
United Kingdom

ORCID ID	0000-0003-0284-8630
Phone	+44 (0)1617016942
Email	emma.crosbie@manchester.ac.uk

Study information

Study design	Non-randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Predicting response to progestins for the treatment of endometrial hyperplasia and endometrioid adenocarcinoma of the endometrium
Study acronym	MIRENA
Study objectives	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.
Ethics approval(s)	NRES committee North West Haydock; 07/03/2014; 14/NW/0056
Health condition(s) or problem(s) studied	Endometrial hyperplasia and endometrioid adenocarcinoma of the endometrium
Intervention	Current intervention as of 11/04/2023: 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 60 months. Predictive biomarkers of clinical responsiveness to progestin treatment will be identified using pre-treatment blood and biopsy samples. _____ Previous 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
Primary outcome measure	Current primary outcome measure as of 11/04/2023: Ki-67 and progesterone receptor status; Timepoint(s): At approximately 3-monthly intervals (for up to a total of 60 months) _____ Previous 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 study start date	16/06/2014
Completion date	01/01/2027

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	Planned Sample Size: 150; UK Sample Size: 150
Key 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
Key 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
Date of first enrolment	16/06/2014
Date of final enrolment	14/06/2019

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

St Mary's Hospital

Oxford Road
Manchester
M13 9WL
United Kingdom

Sponsor information

Central Manchester University Hospitals NHS Trust (CMFT) (UK)
Hospital/treatment centre

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

"ROR"	https://ror.org/00he80998

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

11/04/2023: The following changes have been made:
1. The scientific contact has been changed.
2. The IRAS number has been added.
3. The overall trial end date has been changed from 14/06/2019 to 01/01/2027.
4. The target number of participants has been changed from 30 to 150.
5. The intervention has been changed.
6. The primary outcome measure has been changed.
7. Central Manchester & Manchester Children's Hospital NHS Trust has been removed and St Mary's Hospital added to the trial participating centres.
03/04/2019: The condition has been changed from "Topic: Cancer; Subtopic: Gynaecological Cancer; Disease: Uterus/Endometrium" to "Endometrial hyperplasia and endometrioid adenocarcinoma of the endometrium" following a request from the NIHR.
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.