Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-28 @ 11:23 PM
Study NCT ID:
NCT05812235
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-24
First Post:
2023-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Microstructure by Using HR-pQCT After Esophagectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}], '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': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016629', 'term': 'Esophagectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Protein'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 118}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-21', 'studyFirstSubmitDate': '2023-04-02', 'studyFirstSubmitQcDate': '2023-04-02', 'lastUpdatePostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparing bone microstructure in control and Esophagectomy groups', 'timeFrame': '1day', 'description': 'volumetric bone mineral density'}], 'secondaryOutcomes': [{'measure': 'Comparing bone microstructure with serum biomarkers of osteoporosis', 'timeFrame': '1day', 'description': 'Correlation between bone mineral density in esophagectomy and biomarkers (25-hydroxyvitaminD, calcium, iPTH, P1NP, ICTP, TRACP5b)'}, {'measure': 'Comparing bone microstructure with dual-energy X-ray absorptiometry', 'timeFrame': '1day', 'description': 'Correlation of bone mineral density between esophagectomy and DXA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoporosis', 'Sarcopenia', 'Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'Esophagectomy is most curative treatment to esophageal cancer. However, osteoporosis , which is characterized by both the loss of bone mass and the deterioration of bone architecture, is a serious complication in the long course after surgery. The aim of the present study was to evaluate osteoporosis by using high-resolution peripheral quantitative computed tomography (HR-pQCT) in the long course after esophagectomy. At least 3 years should have elapsed since operation without recurrence of esophageal cancer.', 'detailedDescription': 'The patients after esophagectomy loss appetite and decrease the weight. Esophagectomy especially cause severe sarcopenia and metabolic change. Osteoporosis, which is characterized by both the loss of bone mass and the deterioration of bone architecture, is a serious complication in the long course after esophagectomy. The primary tools for assessing volumetric density and bone structure are quantitative computed tomography (QCT) and more recently, high-resolution peripheral quantitative computed tomography (HR-pQCT). However the validation of osteoporosis with HR-pQCT in the long course after esophagectomy remain elusive. The aim of the present study was to evaluate osteoporosis by using HR-pQCT in the long course after esophagectomy. At least 3 years should have elapsed since esophagectomy without any recurrence.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Japanese', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 3 years have elapsed since esophagectomy due to esophageal cancer\n* Provide signed informed consent\n\nExclusion Criteria:\n\n* Current use of the following osteoporosis agents; Teriparatide, Denosumab, and - -\n* bisphosphonate\n* Present malignancy (except in situ carcinoma)\n* Radiotherapy\n* Any condition that required chronic (greater than three months cumulative and greater than 5 mg/day) glucocorticoid therapy\n* Other diseases which affect bone metabolism Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures Received \\> 3 months (or equivalent) of osteoporosis treatment Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).'}, 'identificationModule': {'nctId': 'NCT05812235', 'briefTitle': 'Bone Microstructure by Using HR-pQCT After Esophagectomy', 'organization': {'class': 'OTHER', 'fullName': 'Nagasaki University'}, 'officialTitle': 'Bone Microstructure by Using High-resolution Peripheral Quantitative Computed Tomography After Esophagectomy', 'orgStudyIdInfo': {'id': 'NagasakiU3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Esophagectomy', 'description': '48 patients with esophagectomy due to esophageal cancer before no more than 3 years', 'interventionNames': ['Procedure: esophagectomy']}, {'label': 'Healthy Control', 'description': '70 patients without gastrectomy , who are similar background in other group, are collected from date Pathologic analysis of primary osteoporosis: investigating age and osteoporosis related changes of bone microstructure by using HR-pQCT (UMIN000023535)'}], 'interventions': [{'name': 'esophagectomy', 'type': 'PROCEDURE', 'description': 'esophagectomy', 'armGroupLabels': ['Esophagectomy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Shinichiro Kobayashi', 'role': 'CONTACT', 'email': 'shinichirokobayashi@nagasaki-u.ac.jp', 'phone': '0958197316'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nagasaki University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Surgery', 'investigatorFullName': 'Kobayashi Shinichiro', 'investigatorAffiliation': 'Nagasaki University'}}}}