Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer

Conditions
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Endometrial Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Female Group 2<br>Females with BMI >30 kg/m2 who are having a hysterectomy for benign conditions | |
| Females Group 1<br>Females with BMI <30 kg/m2 who are having a hysterectomy for benign conditions | |
| Males<br>2 males with BMI <30 kg/m2 and 2 males with BMI >30 kg/m2 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrial cancer, Obesity