Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-01 @ 6:00 AM
Study NCT ID:
NCT02226302
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2014-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Omental fat samples will be stored for one year for study purposes. They will not be stored for future research'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-07', 'studyFirstSubmitDate': '2014-06-11', 'studyFirstSubmitQcDate': '2014-08-25', 'lastUpdatePostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'measure': 'Examine how expression of estrogen response genes are altered in obesity', 'timeFrame': 'Baseline', 'description': 'Compare gene response in tissue from lean and obese individuals'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endometrial cancer', 'Obesity'], 'conditions': ['Endometrial Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80 years\n* Any patient having abdominal surgery (Laparoscopic or open technique) for benign conditions\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Patients must have adequate:\n* Hematologic function: Neutrophils ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L\n* Renal function: serum creatinine ≤ ULN or estimated glomerular filtration rate (eGFR) \\[CKD-EPI Formula\\] ≥ 60 mL/min\n* Hepatic function: serum bilirubin ≤ 1.5 x ULN and AST ≤ 2.5 x ULN and ALT≤ 2.5 x ULN\n* Physically able to undergo surgery\n* Written informed consent\n\nExclusion Criteria:\n\n* Confirmed gynaecological malignancy\n* Contraindications and/or unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);\n* Patients who are pregnant or lactating\n* 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.\n* Patients with disseminated intra-peritoneal malignancy or suspected ovarian cancer\n* HIV positive\n* Previous bariatric surgery'}, 'identificationModule': {'nctId': 'NCT02226302', 'acronym': 'FETCH', 'briefTitle': 'Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Queensland Centre for Gynaecological Cancer'}, 'officialTitle': 'Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer', 'orgStudyIdInfo': {'id': 'FETCH'}}, 'armsInterventionsModule': {'armGroups': [{'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'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4108', 'city': 'Coopers Plains', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Queen Elizabeth II Jubilee Hospital', 'geoPoint': {'lat': -27.56463, 'lon': 153.04067}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': "Royal Brisbane and Women's Hospital", 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}], 'overallOfficials': [{'name': 'Donal Brennan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queensland Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queensland Centre for Gynaecological Cancer', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Queensland Institute of Medical Research', 'class': 'OTHER'}, {'name': "Royal Brisbane and Women's Hospital", 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}