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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

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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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
Responsible Party Queensland Centre for Gynaecological Cancer
Study Sponsor Queensland Centre for Gynaecological Cancer
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