Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-02-18 @ 4:46 PM
Study NCT ID:
NCT01738269
Status:
COMPLETED
Last Update Posted:
2013-07-31
First Post:
2012-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elecsys HE4 Chinese Reference Value Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal 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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2351}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-30', 'studyFirstSubmitDate': '2012-11-28', 'studyFirstSubmitQcDate': '2012-11-28', 'lastUpdatePostDateStruct': {'date': '2013-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establish reference in Chinese population', 'timeFrame': 'October 2012 - March 2013'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ovarian cancer, HE4, normal range'], 'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'Aim of this study is to provide specimens for establishing reference values of HE4 in an apparently healthy Chinese population using the Roche Elecsys HE4 assay tested on variety of Elecsys and cobas brand immunoassay analyzers. This reference range will be compared to population of subjects who have signs and symptoms of various benign and malignant diseases, including ovarian cancer. This reference range will also be compared to the levels of HE4 in individual subjects who have been diagnosed with ovarian cancer and are being followed longitudinally for recurrence or progression of their disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Except for samples from apparently healthy subjects, specimens for the entire clinical section are supposed to be available in banks / archives. Thus, for the most part, no prospective collection of serum should be necessary. Pseudonymized residual samples will be used. All elements of the clinical part require samples from well characterized cohorts are showed below.\n\n1. Apparently Healthy: 300\n2. Non-malignant Conditions: 650\n3. Malignant Conditions: 800', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (all cohorts):\n\n* appropriate clinical data\n* normal appearance of sample\n* minimum 0.5 ml volume available\n\nExclusion Criteria (all cohorts):\n\n* \\< 18 years of age\n* insufficient volume\n* insufficient clinical information\n* \\> 3 freeze/thaw cycles of samples\n* Stored or shipped at \\> 0°C\n* Icteric, lipemic, hemolytic, substantial particulates'}, 'identificationModule': {'nctId': 'NCT01738269', 'briefTitle': 'Elecsys HE4 Chinese Reference Value Study', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'A Multi-center Reference Value Study of Elecsys HE4 in Chinese Population', 'orgStudyIdInfo': {'id': 'CIM RD001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Apparently healthy subjects'}, {'label': 'Non-malignant conditions subjects'}, {'label': 'Malignant conditions subjects'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'China PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Fuzhou', 'country': 'China', 'facility': 'The First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'Sun Yat-Sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Jinan', 'country': 'China', 'facility': 'Shandong University Qilu Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin Cancer Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Ürümqi', 'country': 'China', 'facility': 'Xinjiang Medical University Cancer Center', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'city': 'Wuhan', 'country': 'China', 'facility': 'Tongji Hospital Tongji Medical Colege of HUST', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Xiamen', 'country': 'China', 'facility': 'Zhongshan Hospital Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Biochemistry Department', 'investigatorFullName': 'Yaping Tian', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}