Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-28 @ 4:34 PM
Study NCT ID:
NCT04488432
Status:
COMPLETED
Last Update Posted:
2020-09-11
First Post:
2020-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endocrine, Bone And Metabolic Disorders In Adults After Allogeneic Stem-cell Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D000309', 'term': 'Adrenal Insufficiency'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-10', 'studyFirstSubmitDate': '2020-07-23', 'studyFirstSubmitQcDate': '2020-07-23', 'lastUpdatePostDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adrenal insuffisiency prevalence', 'timeFrame': '12 month post-alloHSCT', 'description': 'insulin hypoglycemia test'}], 'secondaryOutcomes': [{'measure': 'Hypothyroidism prevalence', 'timeFrame': '12 month post-alloHSCT', 'description': 'fT4, TSH'}, {'measure': 'Growth hormon Deficiency prevalence', 'timeFrame': '12 month post-alloHSCT', 'description': 'insulin hypoglycemia test'}, {'measure': 'Premature ovarian failure prevalence', 'timeFrame': '12 month post-alloHSCT', 'description': 'FSH, LH, estradiol'}, {'measure': 'Prevalence of elevated FSH in men', 'timeFrame': '12 month post-alloHSCT', 'description': 'FSH, testosterone'}, {'measure': 'Prevalence of low bone mineral density', 'timeFrame': '12 month post-alloHSCT', 'description': 'dual X-ray absorptiometry'}, {'measure': 'Prevalence of obesity', 'timeFrame': '12 month post-alloHSCT', 'description': 'BMI'}, {'measure': 'Prevalence of dyslipidemia', 'timeFrame': '12 month post-alloHSCT'}, {'measure': 'Prevalence of hyperglycemia and insulin-resistance', 'timeFrame': '12 month post-alloHSCT', 'description': 'glycemia and HOMA2-IR index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endocrine System Diseases', 'Osteoporosis', 'Metabolic Syndrome', 'Adrenal Insufficiency']}, 'descriptionModule': {'briefSummary': 'Allogeneic hematopoietic stem cell transplantations (allo-HSCT) is often indicated in malignant hematologic diseases. Conditioning regimens, used to reduce the tumor burden and to prevent transplant rejection, are based on chemotherapy alone or combined with total body irradiation (TBI). Endocrine complications are frequent transplant-related side effects. Investigators have been well described in children studies but less in adulthood.\n\nThe objective of this study is to assess retrospectively endocrine, bone and metabolic disorders in adult patients, 12 months after allo-HSCT.', 'detailedDescription': 'Patients \\& Methods Inclusion criteria are : patients treated with allo-HSCT from 2006 to 2016 for a malignant hematologic disease; adult and in complete remission at exploration.\n\nExclusion criteria are : anteriority of brain radiotherapy and prior HSCT.\n\nTwelve months after HSCT, each patient underwent fasting measurement of IGF1, TSH, fT4, FSH, LH, sex steroids, glycemia, insulin level, and lipid profile. Unless contraindication, adrenal and growth hormone functions were assessed with insulin hypoglycemia test. A dual X-ray absorptiometry was also performed.\n\nInvestigators will assess the prevalence of endocrine, bone and metabolic disorders 12 months after allo-HSCT and describe some of their risk factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with allo-HSCT after puberty from 2006 to 2016 in our University Hospital of Brest, adult at the endocrine exploration.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients treated with allo-HSCT from 2006 to 2016 for a malignant hematologic disease\n* adult and in complete remission at exploration.\n\nExclusion Criteria:\n\n* anteriority of brain radiotherapy\n* prior HSCT\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT04488432', 'acronym': 'ENDOCALLOGREFF', 'briefTitle': 'Endocrine, Bone And Metabolic Disorders In Adults After Allogeneic Stem-cell Transplant', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Endocrine, Bone And Metabolic Disorders In Adults After Allogeneic Stem-cell Transplant', 'orgStudyIdInfo': {'id': '29BRC19.0137'}}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU de Brest - Endocrinology and Diabetology Department', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}