Brief Title
Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer
Official Title
Linking Obesity and Estrogen-responsive Genes in Endometrial 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.
Study Type
Observational
Primary Outcome
Identify estrogen-response genes in endometrial cancer
Secondary Outcome
Examine how expression of estrogen response genes are altered in obesity
Condition
Endometrial Cancer
Study Arms / Comparison Groups
Female Group 2
Description: Females with BMI >30 kg/m2 who are having a hysterectomy for benign conditions
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
16
Start Date
July 2014
Completion Date
December 2021
Primary Completion Date
May 2018
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
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Donal Brennan, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT02226302
Organization ID
FETCH
Responsible Party
Sponsor
Study Sponsor
Queensland Centre for Gynaecological Cancer
Collaborators
Queensland Institute of Medical Research
Study Sponsor
Donal Brennan, Principal Investigator, Queensland Health
Verification Date
April 2020