Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-30 @ 11:58 PM
Study NCT ID:
NCT03359304
Status:
NOT_YET_RECRUITING
Last Update Posted:
2017-12-02
First Post:
2017-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Neurofibromatosis-associated Tumor Biobank
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017253', 'term': 'Neurofibromatoses'}, {'id': 'D001859', 'term': 'Bone Neoplasms'}], 'ancestors': [{'id': 'D009455', 'term': 'Neurofibroma'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D020752', 'term': 'Neurocutaneous Syndromes'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "The investigator will collect specimen and blood. If the investigator finds out that the sample doesn't have enough cells to be useful, the investigator may call for an additional sample."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-29', 'studyFirstSubmitDate': '2017-11-25', 'studyFirstSubmitQcDate': '2017-11-29', 'lastUpdatePostDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detected NF-1 gene expression pattern in neurofibromatosis-asociated tumor', 'timeFrame': '3 years', 'description': 'To examine the neurofibromatosis type 1(NF-1) gene expression of the patients with neurofibromatosis-associated tumor'}]}, 'oversightModule': {'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bone tumor'], 'conditions': ['Neurofibromatoses']}, 'descriptionModule': {'briefSummary': 'Neurofibromatosis-associated Tumor is very rare bone tumor. The investigator set up the biobank to ensure every patient has the chance to participate in future research', 'detailedDescription': 'Samples of blood and other stored material such as slides,frozen tissues or leftover diagnostic material.\n\nQuestionnaire information, including health history, growth and development, physical activity and family medical history information.\n\nIf patients have been diagnosed with a neurofibromatosis-associated tumor or another condition the investigator is interested in， the investigator will ask the patient to release medical record information relating to diagnosis and treatment of neurofibromatosis-associated tumor, other cancers, blood disorders, and similar conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Asia', 'eligibilityCriteria': 'Inclusion Criteria:\n\nProband Inclusion criteria: A diagnosis or suspected diagnosis of neurofibromatosis-associated tumor Family member inclusion criteria: Biological parents and full biological siblings of a case diagnosed with neurofibromatosis-associated tumor\n\nExclusion Criteria:\n\nnon-asian'}, 'identificationModule': {'nctId': 'NCT03359304', 'briefTitle': 'The Neurofibromatosis-associated Tumor Biobank', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Establishment of Neurofibromatosis-associated Tumours Biobank for Future Genomic-based Research Aiming at Improved Outcome Prediction', 'orgStudyIdInfo': {'id': 'PKU-MPNST'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kuisheng Liu, phD', 'role': 'CONTACT', 'email': 'tumorcenter@163.com', 'phone': '+8601088324471'}], 'overallOfficials': [{'name': 'Tingting Ren, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ren tingting', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Musculoskeletal Tumor Center', 'investigatorFullName': 'Ren tingting', 'investigatorAffiliation': "Peking University People's Hospital"}}}}