Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT07191951
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Shanghai Clinical Cohort - Adrenal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000307', 'term': 'Adrenal Gland Diseases'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-09-17', 'studyFirstSubmitQcDate': '2025-09-17', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-Treatment Remission Rate', 'timeFrame': 'at least six months or more'}, {'measure': 'Treatment Response Rate', 'timeFrame': 'at least six months or more'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adrenal Disease']}, 'descriptionModule': {'briefSummary': 'As a vital organ responsible for producing life-sustaining hormones, the adrenal gland is associated with a wide range of diseases. These diseases affect multiple systems throughout the body and carry a high rate of mortality and disability. Current diagnosis and treatment face several challenges: significant variability in hormone testing results, inaccurate localization via imaging techniques, unclear molecular characteristics of adrenal tumors, and difficulty in determining prognosis through pathology. Therefore, establishing a clinical research cohort for adrenal diseases is essential. Such a cohort will enable in-depth exploration of disease mechanisms, identification of disease subtypes, optimization of diagnostic criteria, evaluation of treatment efficacy, advancement of personalized medicine, and formulation of prevention and treatment strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Aged between 18 and 75 years; diagnosed with adrenal diseases, including primary aldosteronism, pheochromocytoma, Cushing's syndrome, congenital adrenal hyperplasia, adrenocortical carcinoma, etc.; in stable condition, capable of tolerating all examinations and follow-ups required by the study. These patients receive adrenal surgery, radiotherapy, and/or medication therapy based on diagnosis and subtype classification.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A signed and dated informed consent form\n* Commitment to abide by the study procedures and cooperate with the implementation of the entire study process\n* Patients diagnosed with adrenal diseases, including aldosteronism, Cushing's syndrome, pheochromocytoma, adrenocortical carcinoma, and congenital adrenal hyperplasia; regardless of whether they have received adrenal surgery, radiotherapy, and/or medication therapy\n* Aged between 18 and 75 years\n\nExclusion Criteria:\n\n* Subjects meeting any of the following criteria will be excluded from this study:\n* Refuse to sign the informed consent form\n* Patients without adrenal diseases\n* Have specified diseases or conditions (physical or psychological, identified through physical examination) that warrant exclusion from the study"}, 'identificationModule': {'nctId': 'NCT07191951', 'briefTitle': 'Shanghai Clinical Cohort - Adrenal Disease', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Shanghai Clinical Cohort - Adrenal Disease', 'orgStudyIdInfo': {'id': 'SHDC2025CCS022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adrenal cohort', 'description': "Aged between 18 and 75 years; diagnosed with adrenal diseases, including primary aldosteronism, pheochromocytoma, Cushing's syndrome, congenital adrenal hyperplasia, adrenocortical carcinoma, etc.; in stable condition, capable of tolerating all examinations and follow-ups required by the study.", 'interventionNames': ['Other: Receive adrenal surgery, radiotherapy, and/or medication therapy based on diagnosis and subtype classification.']}], 'interventions': [{'name': 'Receive adrenal surgery, radiotherapy, and/or medication therapy based on diagnosis and subtype classification.', 'type': 'OTHER', 'description': 'Receive adrenal surgery, radiotherapy, and/or medication therapy based on diagnosis and subtype classification.', 'armGroupLabels': ['Adrenal cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yiran Jiang', 'role': 'CONTACT', 'email': 'jyr11662@rjh.com.cn', 'phone': '0086-021-64370045'}], 'facility': 'Jiang yiran', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yiran Jiang', 'role': 'CONTACT', 'email': 'jyr11662@rjh.com.cn', 'phone': '0086-021-64370045'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine', 'class': 'UNKNOWN'}, {'name': 'RenJi Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Public Health Clinical Center', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Department of Endocrinology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine', 'investigatorFullName': 'Wang Weiqing', 'investigatorAffiliation': 'Ruijin Hospital'}}}}