Clinical trial NCT02226302: Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer
Official title: Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Cancer
Keywords: Endometrial cancer
Obesity
Lead sponsor: Queensland Centre for Gynaecological Cancer
Sponsor class: OTHER_GOV
Collaborators: name: Queensland Institute of Medical Research
name: Royal Brisbane and Women's Hospital
First posted: 2014-08-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 12 female patients undergoing surgery for pre-existent conditions will be recruited for this study. The groups will include 6 patients with a BMI \< 30 kg/m2 and 6 patients with a BMI ≥ 35 kg/m2. In addition 4 males patients will be recruited to assess responses from patients with low levels of serum estradiol.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Identify estrogen-response genes in endometrial cancer
timeFrame: Baseline
Secondary outcomes:
measure: Examine how expression of estrogen response genes are altered in obesity
timeFrame: Baseline
Other outcomes:
Locations:
city: Coopers Plains
country: Australia
facility: Queen Elizabeth II Jubilee Hospital
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
Study officials:
affiliation: Queensland Health
name: Donal Brennan
role: PRINCIPAL_INVESTIGATOR
References: