Clinical trial · Observational
Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer
NCT02226302CI-TRIAL-00053796FETCHcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Female Group 2
- description
- Females with BMI \>30 kg/m2 who are having a hysterectomy for benign conditions
- label
- Females Group 1
- description
- Females with BMI \<30 kg/m2 who are having a hysterectomy for benign conditions
- label
- Males
- description
- 2 males with BMI \<30 kg/m2 and 2 males with BMI \>30 kg/m2
Primary outcomes (1)
- measure
- Identify estrogen-response genes in endometrial cancer
- timeFrame
- Baseline
- description
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.