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OpenTrials
Completed

NCT Number: NCT02226302

Linking Obesity and Estrogen-responsive Genes in Endometrial 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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Examine how expression of estrogen response genes are altered in obesity

    Time frame: Baseline

    Compare gene response in tissue from lean and obese individuals

Sponsors and collaborators

Lead sponsor

Queensland Centre for Gynaecological Cancer

Other Gov

Collaborators

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

Registry information

Acronym: FETCH

Important dates

Study start
2014
Primary completion
2018
Study completion
2021
First posted
Aug 27, 2014
Registry last updated
Sep 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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