Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer
Completed
- Conditions
- Endometrial Cancer
- Registration Number
- NCT02226302
- Lead Sponsor
- Queensland Centre for Gynaecological Cancer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identify estrogen-response genes in endometrial cancer Baseline Omental fat will be collected from 6 lean patients, 6 obese patients and 4 controls (male patients) and co-cultured with endometrial cancer cell lines
- Secondary Outcome Measures
Name Time Method Examine how expression of estrogen response genes are altered in obesity Baseline Compare gene response in tissue from lean and obese individuals
Trial Locations
- Locations (2)
Queen Elizabeth II Jubilee Hospital
🇦🇺Coopers Plains, Queensland, Australia
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia