Progesterone therapy for endometrial cancer prevention in obese women
| ISRCTN | ISRCTN40940943 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40940943 |
| Secondary identifying numbers | 18843 |
- Submission date
- 22/04/2015
- Registration date
- 23/04/2015
- Last edited
- 29/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Dr Abi Derbyshire
Scientific
Scientific
St Mary's Hospital Manchester
5th Floor (Research)
St. Mary's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom
Study information
| Study design | Non-randomised; Interventional; Design type: Prevention, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information shee |
| Scientific title | PROgesterone Therapy for Endometrial Cancer prevention in obese women: an interventional trial |
| Study acronym | PROTEC1 |
| Study objectives | 1. To evaluate the efficacy of the Mirena IUS for endometrial protection; including histological impact and the expression of biomarkers of proliferation, apoptosis and other pathways associated with increased risk of endometrial cancer 2. To determine the feasibility, safety and acceptability of using the Mirena IUS for endometrial protection 3. To determine the effect of Mirena IUS insertion on systemic endocrine function and mental and physical wellbeing |
| Ethics approval(s) | 15/EE/0063 |
| Health condition(s) or problem(s) studied | Topic: Cancer, Metabolic and endocrine disorders; Subtopic: Gynaecological Cancer, Metabolic and Endocrine (all Subtopics); Disease: Uterus/Endometrium, Metabolic & Endocrine (not diabetes) |
| Intervention | Women with a BMI >40 who are seen by the Sleep Apnoea Service at Salford Royal Hospital will be asked if they wish to participate in the trial. They will complete a questionnaire, blood samples and biopsies of the lining of the womb taken before and after insertion of a Mirena IUS. |
| Intervention type | Other |
| Primary outcome measure | 1. Ki-67 |
| Secondary outcome measures | 1. Histopathology 2. Phospho-H3 3. Cleaved Caspase 3, cleaved PARP 4. MAPK signalling molecules and their phosphorylated isoforms 5. P13K-AKT-mTOR signalling molecules and their phosphorylated isoforms 6. PTEN and AMPK, P53 7. Strathmin, cyclin A, c-myc 8. Oestrogen, progesterone, LH, FSH, insulin, adiponectin and leptin receptors 9. IGF-1IR, IGF2, EIG121, RALDH2, SFRP-1, SFRP-4, Survivin 10. Endocrine markers including but not limited to: 11. Fasting serum glucose & insulin, HbA1c, IGFBP-1 and C-peptide levels 12. SHBG, oestrogen, progesterone, free androgen index, FSH, LH, testosterone, CRP 13. Leptin, adiponectin 14. Changes in menstrual function, physical and mental wellbeing |
| Overall study start date | 01/05/2015 |
| Completion date | 01/11/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 40; UK Sample Size: 40 |
| Key inclusion criteria | 1. Women seen in sleep apnoea clinic at Salford Royal Hospital 2. BMI>40 3. Informed consent 4. Aged 18 years or over 5. Not actively trying to lose weight 6. Normal up to date smear 7. Normal endometrial sampling at screening |
| Key exclusion criteria | 1. Previous hysterectomy 2. LNG-IUS or IUD in situ or in previous 6 months 3. Pregnant or breast feeding, previous endometrial ablation 4. Breast cancer 5. Congenital/acquired uterine anomaly 6. Pelvic inflammatory disease or genital actinomycosis 7. Immunodeficiency 8. Mirena IUS contraindicated 9. Taking systemic progestagens 10. Patient actively trying to lose weight (awaiting bariatric surgery) |
| Date of first enrolment | 01/05/2015 |
| Date of final enrolment | 01/08/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Mary's Hospital Manchester
5th Floor (Research)
St. Mary's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom
St. Mary's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom
Sponsor information
National Institute for Health Research
Government
Government
30-32 Hyde Terrace
Leeds
LS2 9LN
United Kingdom
"ROR" |
https://ror.org/0187kwz08 |
|---|
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
29/12/2015: The recruitment end date has been extended to 01/08/2016 from 01/11/2015.
