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

• ClinicalTrials.gov Identifier: NCT02226302
• Recruitment Status: Completed
• First Posted: August 27, 2014
• Last Update Posted: September 9, 2021
• Sponsor: Queensland Centre for Gynaecological Cancer
• Collaborators: Queensland Institute of Medical Research; Royal Brisbane and Women's Hospital
• Information provided by (Responsible Party): Queensland Centre for Gynaecological Cancer

Tracking Information

• First Submitted Date: June 11, 2014
• First Posted Date: August 27, 2014
• Last Update Posted Date: September 9, 2021
• Actual Study Start Date: July 2014
• Actual Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 25, 2014)

Identify estrogen-response genes in endometrial cancer [ Time Frame: Baseline ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 25, 2014)

Examine how expression of estrogen response genes are altered in obesity [ Time Frame: Baseline ]

Compare gene response in tissue from lean and obese individuals

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Omental fat samples will be stored for one year for study purposes. They will not be stored for future research

• 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.
• Condition: Endometrial Cancer
• Intervention: Not Provided

Study Groups/Cohorts

• Female Group 2
  Females with BMI >30 kg/m2 who are having a hysterectomy for benign conditions
• Females Group 1
  Females with BMI <30 kg/m2 who are having a hysterectomy for benign conditions
• Males
  2 males with BMI <30 kg/m2 and 2 males with BMI >30 kg/m2

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: August 25, 2014): 16
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 2021
• Actual Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT02226302
• Other Study ID Numbers: FETCH
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Queensland Centre for Gynaecological Cancer
• Original Responsible Party: Same as current
• Current Study Sponsor: Queensland Centre for Gynaecological Cancer
• Original Study Sponsor: Same as current

Collaborators

• Queensland Institute of Medical Research
• Royal Brisbane and Women's Hospital

Investigators

• Principal Investigator: Donal Brennan; Queensland Health

• PRS Account: Queensland Centre for Gynaecological Cancer
• Verification Date: September 2021