Status:
COMPLETED
Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer
Lead Sponsor:
Queensland Centre for Gynaecological Cancer
Collaborating Sponsors:
Queensland Institute of Medical Research
Royal Brisbane and Women's Hospital
Conditions:
Endometrial Cancer
Eligibility:
All Genders
18-80 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02226302
Start Date
July 1 2014
End Date
August 1 2021
Last Update
September 9 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Queen Elizabeth II Jubilee Hospital
Coopers Plains, Queensland, Australia, 4108
2
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029