Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT03429504
Status:
UNKNOWN
Last Update Posted:
2018-02-12
First Post:
2018-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Body Mass Index on Outcomes of Breast Cancer Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'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': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-02-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-08-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2018-02-06', 'studyFirstSubmitQcDate': '2018-02-06', 'lastUpdatePostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of obese breast cancer patients with response to treatment compared to non obese breast cancer patients.', 'timeFrame': 'The cases will be obtained from the medical records of breast cancer patients admitted to the Clinical Oncology and Nuclear Medicine Department, Assiut University hospital from 1st of January, 2012 - 31st December, 2016'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Breast cancer', 'Body mass index'], 'conditions': ['Obesity and Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '19597985', 'type': 'BACKGROUND', 'citation': 'Deglise C, Bouchardy C, Burri M, Usel M, Neyroud-Caspar I, Vlastos G, Chappuis PO, Ceschi M, Ess S, Castiglione M, Rapiti E, Verkooijen HM. Impact of obesity on diagnosis and treatment of breast cancer. Breast Cancer Res Treat. 2010 Feb;120(1):185-93. doi: 10.1007/s10549-009-0459-1. Epub 2009 Jul 14.'}, {'pmid': '27930630', 'type': 'BACKGROUND', 'citation': 'Yung RL, Ligibel JA. Obesity and breast cancer: risk, outcomes, and future considerations. Clin Adv Hematol Oncol. 2016 Oct;14(10):790-797.'}, {'pmid': '20571870', 'type': 'BACKGROUND', 'citation': 'Protani M, Coory M, Martin JH. Effect of obesity on survival of women with breast cancer: systematic review and meta-analysis. Breast Cancer Res Treat. 2010 Oct;123(3):627-35. doi: 10.1007/s10549-010-0990-0. Epub 2010 Jun 23.'}, {'pmid': '22106549', 'type': 'BACKGROUND', 'citation': 'Ligibel J. Obesity and breast cancer. Oncology (Williston Park). 2011 Oct;25(11):994-1000.'}, {'pmid': '22562122', 'type': 'BACKGROUND', 'citation': 'Niraula S, Ocana A, Ennis M, Goodwin PJ. Body size and breast cancer prognosis in relation to hormone receptor and menopausal status: a meta-analysis. Breast Cancer Res Treat. 2012 Jul;134(2):769-81. doi: 10.1007/s10549-012-2073-x. Epub 2012 May 5.'}, {'pmid': '20547990', 'type': 'BACKGROUND', 'citation': 'Sestak I, Distler W, Forbes JF, Dowsett M, Howell A, Cuzick J. Effect of body mass index on recurrences in tamoxifen and anastrozole treated women: an exploratory analysis from the ATAC trial. J Clin Oncol. 2010 Jul 20;28(21):3411-5. doi: 10.1200/JCO.2009.27.2021. Epub 2010 Jun 14.'}]}, 'descriptionModule': {'briefSummary': 'Obesity has been linked to an increased risk of developing a number of malignancies, including postmenopausal breast cancer. One of the established risk factors for breast cancer development in post-menopausal women is obesity which has further been linked to breast cancer recurrence and poorer survival in pre- and post-menopausal breast cancer.', 'detailedDescription': 'The biological mechanisms underlying the association between obesity and breast cancer could involve interacting mediators of hormones, adipocytokines, and inflammatory cytokines which link to cell survival or apoptosis, migration and proliferation. Higher level of oestradiol produced in postmenopausal women through aromatization of androgens in the adipose tissues and higher level of insulin, a condition common in obese women, are linked to poorer prognosis in breast cancer. A possible interaction between leptin, insulin and obesity-related markers of inflammation have also been linked to breast cancer outcomes. Non-biological mechanisms could include chemotherapy under-dosing in obese women, suboptimal treatment, and obesity-related complications.\n\nThe impact of body mass index on treatment outcome in patients receiving endocrine therapy, there have been consistent results indicating that the efficacy of aromatase inhibitors vary with body mass index; however, the efficacy of tamoxifen is not body mass index-dependent. In the Arimidex, Tamoxifen, Alone or in Combination trial, which compared the efficacy of anastrozole against tamoxifen as an adjuvant treatment for hormone receptor-positive post-menopausal breast cancer patients, anastrozole, a non-steroidal aromatase inhibitor, was significantly less effective in post-menopausal breast cancer patients with a high body mass index, whereas an equal efficacy of tamoxifen was shown across all body mass index levels.\n\nObservational study. Retrospective analysis of data that will be collected from breast cancer patients medical records as body mass index and their response to treatment, progression free survival and overall survival.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with breast cancer that was admitted at clinical oncology and nuclear medicine department, Assiut University Hospital, Egypt', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Medical records of female Patients with breast cancer at clinical oncology and nuclear medicine department, Assiut University Hospital between (1st Jan 2012 and 31st Dec 2016), their recorded body mass index and their follow up will be included in the study.\n\nExclusion Criteria:\n\n* Patients' medical records that had no documented weight and height.\n* Patients' medical records that had no documented follow up."}, 'identificationModule': {'nctId': 'NCT03429504', 'briefTitle': 'Impact of Body Mass Index on Outcomes of Breast Cancer Management', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Impact of Body Mass Index on Outcomes of Breast Cancer Management (Retrospective Study)', 'orgStudyIdInfo': {'id': 'BMIBC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese breast cancer patients', 'description': 'Response to treatment and progression free survival in obese breast cancer patients'}, {'label': 'non obese breast cancer patients', 'description': 'Response to treatment and progression free survival in non obese breast cancer patients'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Samir S Mohamed, MD', 'role': 'CONTACT', 'email': 'samir@aun.edu.eg', 'phone': '00201222302375'}, {'name': 'Abeer F Amin, MD', 'role': 'CONTACT', 'email': 'aminabeer@yahoo.com', 'phone': '00201017483475'}], 'overallOfficials': [{'name': 'Aiat M Mohamed, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Moheb Ibrahim Melek', 'investigatorAffiliation': 'Assiut University'}}}}