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

September 7, 2021 updated by: Queensland Centre for Gynaecological Cancer
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Coopers Plains, Queensland, Australia, 4108
        • Queen Elizabeth II Jubilee Hospital
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women'S Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examine how expression of estrogen response genes are altered in obesity
Time Frame: Baseline
Compare gene response in tissue from lean and obese individuals
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queensland Centre for Gynaecological Cancer

Collaborators

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

Investigators

  • Principal Investigator: Donal Brennan, Queensland Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

June 11, 2014

First Submitted That Met QC Criteria

August 25, 2014

First Posted (Estimate)

August 27, 2014

Study Record Updates

Last Update Posted (Actual)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 7, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FETCH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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