Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2025-12-30 @ 8:29 PM
Study NCT ID:
NCT05018195
Status:
UNKNOWN
Last Update Posted:
2021-08-24
First Post:
2021-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adipocytokines 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'}, {'id': 'D007249', 'term': 'Inflammation'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups: women receive surgery for benign gynecologic lesions and women receive surgery for endometrial cancer'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-07-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-18', 'studyFirstSubmitDate': '2021-08-18', 'studyFirstSubmitQcDate': '2021-08-18', 'lastUpdatePostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adipocytokines profile', 'timeFrame': 'During operation', 'description': 'Adipocytokines including leptin, adiponectin, visfatin, resistin, omentin, IL-1β, IL-6, IL-8, IL-10, TNF-α, IFNγ'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Inflammation', 'Adiponectin', 'Endometrial cancer'], 'conditions': ['Endometrial Cancer']}, 'referencesModule': {'references': [{'pmid': '30548482', 'type': 'RESULT', 'citation': 'Sung H, Siegel RL, Torre LA, Pearson-Stuttard J, Islami F, Fedewa SA, Goding Sauer A, Shuval K, Gapstur SM, Jacobs EJ, Giovannucci EL, Jemal A. Global patterns in excess body weight and the associated cancer burden. CA Cancer J Clin. 2019 Mar;69(2):88-112. doi: 10.3322/caac.21499. Epub 2018 Dec 12.'}, {'pmid': '12914829', 'type': 'RESULT', 'citation': 'Lin YC, Yen LL, Chen SY, Kao MD, Tzeng MS, Huang PC, Pan WH. Prevalence of overweight and obesity and its associated factors: findings from National Nutrition and Health Survey in Taiwan, 1993-1996. Prev Med. 2003 Sep;37(3):233-41. doi: 10.1016/s0091-7435(03)00119-1.'}, {'pmid': '16775581', 'type': 'RESULT', 'citation': 'Chen LJ, Fox KR, Haase A, Wang JM. Obesity, fitness and health in Taiwanese children and adolescents. Eur J Clin Nutr. 2006 Dec;60(12):1367-75. doi: 10.1038/sj.ejcn.1602466. Epub 2006 Jun 14.'}, {'pmid': '28254229', 'type': 'RESULT', 'citation': 'Lai JC, Weng CS, Huang SM, Huang N, Chou YJ, Wang CC, Wang KL. Incidence and lifetime risk of uterine corpus cancer in Taiwanese women from 1991 to 2010. Taiwan J Obstet Gynecol. 2017 Feb;56(1):68-72. doi: 10.1016/j.tjog.2015.09.010.'}, {'pmid': '27903152', 'type': 'RESULT', 'citation': 'Hopkins BD, Goncalves MD, Cantley LC. Obesity and Cancer Mechanisms: Cancer Metabolism. J Clin Oncol. 2016 Dec 10;34(35):4277-4283. doi: 10.1200/JCO.2016.67.9712. Epub 2016 Nov 7.'}, {'pmid': '30341040', 'type': 'RESULT', 'citation': 'Rakotoarivelo V, Lacraz G, Mayhue M, Brown C, Rottembourg D, Fradette J, Ilangumaran S, Menendez A, Langlois MF, Ramanathan S. Corrigendum to "Inflammatory cytokine profiles in visceral and subcutaneous adipose tissues of obese patients undergoing bariatric surgery reveal lack of correlation with obesity or diabetes" EBioMedicine 30C (2018) 237-247. EBioMedicine. 2018 Nov;37:564-568. doi: 10.1016/j.ebiom.2018.10.025. Epub 2018 Oct 16. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Endometrial cancer incidence rates were increasing in the past two decades with a continuous rising trend in Taiwan. Uterine cancer was attributable to obesity based on their association with excess body weight in most epidemiological cohort studies. However, the prevalence of obesity was lower in Taiwan.Therefore, we will study if adipose tissues depots in different locations of body could reflect or correlate the pathogenesis of endometrial cancer.', 'detailedDescription': 'Besides lipid metabolism, adipose tissue plays import roles in regulation of hormones, adipokines, cytokines and immunocytes. Adipose tissue is now known as endocrine organ which to express and secrete a variety of bioactive peptides, known as adipokines. We will evaluate the difference various adipocytokines between visceral and subcutaneous adipose tissues between women with benign lesions and endometrial cancer. We will study the inter-individual differences in adipocytokines between two types of adipose tissues and their correlation with image quantification.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'Women received gynecologic surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen diagnosed with primary endometrial cancer and undergo surgery, with or without adjuvant therapy in our hospital (EmCa group); women received surgery for benign pelvic lesions in our hospital (control group)\n\nExclusion Criteria:\n\nWomen with an underlying malignancy or any concomitant malignancy, prior chemotherapy or radiation before diagnosis of endometrial cancer, history of autoimmune diseases or immunosuppressive agent use'}, 'identificationModule': {'nctId': 'NCT05018195', 'acronym': 'ACEmCa', 'briefTitle': 'Adipocytokines in Endometrial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Profile of Adipocytokines in Patients With Endometrial Cancer: Focus on Various Types of Adipose Tissues', 'orgStudyIdInfo': {'id': '202106074RIND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Benign', 'description': 'Women who receive surgery for benign lesions including leiomyoma, adenomyosis, or ovarian cysts. We will obtain one 5\\*5 cm omental fat and one 3\\*3 cm subcutaneous adipose tissue during surgery.', 'interventionNames': ['Procedure: Excise adipose tissue']}, {'type': 'EXPERIMENTAL', 'label': 'Endometrial cancer', 'description': 'Women who receive surgery(staging or cytoreductive surgery) for endometrial cancer. We will obtain one 5\\*5 cm omental fat and one 3\\*3 cm subcutaneous adipose tissue during surgery.', 'interventionNames': ['Procedure: Excise adipose tissue']}], 'interventions': [{'name': 'Excise adipose tissue', 'type': 'PROCEDURE', 'description': 'Perform partial omentectomy to obtain one 5\\*5 cm omental fat and excise one 3\\*3 cm subcutaneous adipose tissue( 2 finger width above the pubic symphysis) during surgery', 'armGroupLabels': ['Benign', 'Endometrial cancer']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chin Chi Tang', 'role': 'CONTACT', 'email': 'stardom7370@gmail.com', 'phone': '886-23123456', 'phoneExt': '71964'}, {'name': 'Yi Jou Tai', 'role': 'CONTACT', 'email': '017363@ntuh.gov.tw', 'phone': '8869721653'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Share the adipocytokines profile raw data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}