Condition category
Cancer
Date applied
22/04/2015
Date assigned
23/04/2015
Last edited
29/12/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Abi Derbyshire

ORCID ID

Contact details

St Mary's Hospital Manchester
5th Floor (Research)
St. Mary's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18843

Study information

Scientific title

PROgesterone Therapy for Endometrial Cancer prevention in obese women: an interventional trial

Acronym

PROTEC1

Study hypothesis

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

15/EE/0063

Study design

Non-randomised; Interventional; Design type: Prevention, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a participant information shee

Condition

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

Phase

Phase II

Drug names

Primary outcome measures

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 trial start date

01/05/2015

Overall trial end date

01/11/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 40; UK Sample Size: 40

Participant 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)

Recruitment start date

01/05/2015

Recruitment end date

01/08/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Mary's Hospital Manchester
5th Floor (Research) St. Mary's Hospital Oxford Road
Manchester
M13 9WL
United Kingdom

Sponsor information

Organisation

National Institute for Health Research

Sponsor details

30-32 Hyde Terrace
Leeds
LS2 9LN
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

29/12/2015: The recruitment end date has been extended to 01/08/2016 from 01/11/2015.