Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer (FETCH)

Queensland Centre for Gynaecological Cancer

Status

Completed

Conditions

Endometrial Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT02226302

FETCH

Details and patient eligibility

About

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.

Enrollment

16 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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