Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02226302

Acronym

FETCH

Enrollment

Registered

2014-08-27

Start date

2014-07-31

Completion date

2021-08-31

Last updated

2021-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

Keywords

Endometrial cancer, Obesity

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Identify estrogen-response genes in endometrial cancer	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

Measure	Time frame	Description
Examine how expression of estrogen response genes are altered in obesity	Baseline	Compare gene response in tissue from lean and obese individuals

Countries

Australia

Outcome results