Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer

NCT ID: NCT02226302

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2021-08-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Female Group 2

Females with BMI \>30 kg/m2 who are having a hysterectomy for benign conditions

No interventions assigned to this group

Females Group 1

Females with BMI \<30 kg/m2 who are having a hysterectomy for benign conditions

No interventions assigned to this group

Males

2 males with BMI \<30 kg/m2 and 2 males with BMI \>30 kg/m2

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Queensland Institute of Medical Research

OTHER

Sponsor Role: collaborator

Royal Brisbane and Women's Hospital

OTHER_GOV

Sponsor Role: collaborator

Queensland Centre for Gynaecological Cancer

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donal Brennan

Role: PRINCIPAL_INVESTIGATOR

Queensland Health

Locations

Queen Elizabeth II Jubilee Hospital

Coopers Plains, Queensland, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Countries

Australia

Other Identifiers

FETCH

Identifier Type: -

Identifier Source: org_study_id