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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02226302




Registration number
NCT02226302
Ethics application status
Date submitted
11/06/2014
Date registered
27/08/2014
Date last updated
9/09/2021

Titles & IDs
Public title
Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer
Scientific title
Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer
Secondary ID [1] 0 0
FETCH
Universal Trial Number (UTN)
Trial acronym
FETCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Female Group 2 - Females with BMI \>30 kg/m2 who are having a hysterectomy for benign conditions

Females Group 1 - Females with BMI \<30 kg/m2 who are having a hysterectomy for benign conditions

Males - 2 males with BMI \<30 kg/m2 and 2 males with BMI \>30 kg/m2
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Identify estrogen-response genes in endometrial cancer
Timepoint [1] 0 0
Baseline
Secondary outcome [1] 0 0
Examine how expression of estrogen response genes are altered in obesity
Timepoint [1] 0 0
Baseline

Eligibility
Key inclusion criteria
* Age 18-80 years
* Any patient having abdominal surgery (Laparoscopic or open technique) for benign conditions
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Patients must have adequate:
* Hematologic function: Neutrophils = 1.5 x 109/L and platelets = 100 x 109/L
* Renal function: serum creatinine = ULN or estimated glomerular filtration rate (eGFR) [CKD-EPI Formula] = 60 mL/min
* Hepatic function: serum bilirubin = 1.5 x ULN and AST = 2.5 x ULN and ALT= 2.5 x ULN
* Physically able to undergo surgery
* Written informed consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Confirmed gynaecological malignancy
* Contraindications and/or unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
* Patients who are pregnant or lactating
* Serious illness or medical condition but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (patients with stable AF are eligible), or psychiatric illness/social situations that would limit compliance with study requirements.
* Patients with disseminated intra-peritoneal malignancy or suspected ovarian cancer
* HIV positive
* Previous bariatric surgery

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2021
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment postcode(s) [1] 0 0
4108 - Coopers Plains
Recruitment postcode(s) [2] 0 0
4029 - Herston

Funding & Sponsors
Primary sponsor type
Government body
Name
Queensland Centre for Gynaecological Cancer
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Queensland Institute of Medical Research
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Royal Brisbane and Women's Hospital
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The objective is to develop an organotypic model to assess the effects of obesity on the expression and methylation status of estrogen-responsive genes in endometrial cancer. Omental fat samples will be removed from participants during surgery and these fat samples will be used in laboratory analyses.
Trial website
https://clinicaltrials.gov/study/NCT02226302
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Donal Brennan
Address 0 0
Queensland Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02226302