Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer

NCT02226302 | Completed

• 1 other identifier: FETCH
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Endometrial Cancer

Keywords

Endometrial cancer; Obesity

Outcome Measures

Primary Outcomes (1)

• Identify estrogen-response genes in endometrial cancer

  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 Outcomes (1)

• Examine how expression of estrogen response genes are altered in obesity

  Baseline

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queensland Centre for Gynaecological Cancer: lead
• Queensland Institute of Medical Research: collaborator
• Royal Brisbane and Women's Hospital: collaborator

Study Sites (2)

Queen Elizabeth II Jubilee Hospital

Coopers Plains, Queensland, 4108, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

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

MeSH Terms

Conditions

Endometrial Neoplasms; Obesity

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Donal Brennan

  Queensland Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: August 27, 2014
• Study Start: July 1, 2014
• Primary Completion: May 1, 2018
• Study Completion: August 1, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-09

Locations

AU (2)