Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer

Endometrial Cancer Clinical Trial

— FETCH  

Official title:

Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02226302
• Other study ID #: FETCH
• Status: Completed
• Start date: July 2014
• Est. completion date: August 2021

Study information

• Verified date: September 2021
• Source: Queensland Centre for Gynaecological Cancer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2021
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Obesity

Locations

Country	Name	City	State
Australia	Queen Elizabeth II Jubilee Hospital	Coopers Plains	Queensland
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland

Sponsors (3)

Lead Sponsor	Collaborator
Queensland Centre for Gynaecological Cancer	Queensland Institute of Medical Research, Royal Brisbane and Women's Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify estrogen-response genes in endometrial cancer	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	Baseline
Secondary	Examine how expression of estrogen response genes are altered in obesity	Compare gene response in tissue from lean and obese individuals	Baseline