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

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

Study Description
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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.

Condition or disease
Endometrial Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer
Actual Study Start Date : July 2014
Actual Primary Completion Date : May 2018
Actual Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Omental fat samples will be stored for one year for study purposes. They will not be stored for future research

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226302


Locations
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Australia, Queensland
Queen Elizabeth II Jubilee Hospital
Coopers Plains, Queensland, Australia, 4108
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Sponsors and Collaborators
Queensland Centre for Gynaecological Cancer
Queensland Institute of Medical Research
Royal Brisbane and Women's Hospital
Investigators
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Principal Investigator: Donal Brennan Queensland Health
More Information
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Responsible Party: Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier: NCT02226302    
Other Study ID Numbers: FETCH
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: September 2021
Keywords provided by Queensland Centre for Gynaecological Cancer:
Endometrial cancer
Obesity
Additional relevant MeSH terms:
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Endometrial Neoplasms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
 Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases