MIrena coil to Reduce Endometrial Neoplastic Abnormalities
| ISRCTN | ISRCTN31662931 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31662931 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 148213 |
| Protocol serial number | 16746, IRAS 148213 |
| Sponsor | Central Manchester University Hospitals NHS Trust (CMFT) (UK) |
| Funder | National Institute for Health Research |
- 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
Plain English summary of protocol
Contact information
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 |
| emma.crosbie@manchester.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised; Interventional; Design type: Treatment |
| Secondary study design | Non randomised study |
| Study type | Participant 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(s) |
Current primary outcome measure as of 11/04/2023: |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Manchester
M13 9WL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
