Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-03-10 @ 7:59 PM
Study NCT ID:
NCT04263935
Status:
RECRUITING
Last Update Posted:
2025-04-23
First Post:
2020-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Driver Gene Abnormalities and Clinicopathological Characteristics and Disease Prognosis in Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tumor tissue specimen'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-18', 'studyFirstSubmitDate': '2020-02-03', 'studyFirstSubmitQcDate': '2020-02-08', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of driver gene abnormalities', 'timeFrame': 'from the day of the first patient was included to the date of the end of this trial, assessed up to 36 months', 'description': 'the incidence of driver gene abnormalities by fixed gene testing technology'}], 'secondaryOutcomes': [{'measure': 'objective response rate', 'timeFrame': 'from the date of the first patient was included to the date of the end of this trial, assessed up to 36 months', 'description': 'the total proportion of patients with complete response (CR) and partial response (PR)'}, {'measure': '5-year overall survival', 'timeFrame': 'from the date of the first patient was included to the date of the end of this trial, assessed up to 5 years', 'description': 'from the date of first patient was included to the date of death by any cause'}, {'measure': 'Clinicopathological Characteristics', 'timeFrame': 'from the date of the first patient was included to the date of the end of this trial, assessed up to 36 months', 'description': 'study data on clinicopathological characteristics related to incidence of driver gene abnormalities'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lymphoma', 'Driver Gene Abnormalities', 'Disease Prognosis'], 'conditions': ['Lymphoma', 'Gene Abnormality']}, 'descriptionModule': {'briefSummary': 'Correlation Between Driver Gene Abnormalities and Clinicopathological Characteristics and Disease Prognosis in Lymphoma', 'detailedDescription': 'This trial is a prospective non-interventional observational study. The Chinese patients with lymphoma were included and the study data on driver gene abnormalities, demographic characteristics, clinicopathological characteristics and treatment were collected to evaluate the relevance of efficacy and disease prognosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Including demographic characteristics / clinical characteristics / pathological characteristics / treatment and efficacy evaluations.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed as lymphoma (according to WHO 2017 classification criteria)\n2. Life expectancy no less than 3 months\n3. Agreeing to sign the written informed consents\n\nExclusion Criteria:\n\n1. Other malignant tumor history or active malignant tumor need be treated\n2. Researchers determine unsuited to participate in this trial'}, 'identificationModule': {'nctId': 'NCT04263935', 'briefTitle': 'Correlation Between Driver Gene Abnormalities and Clinicopathological Characteristics and Disease Prognosis in Lymphoma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'Correlation Between Driver Gene Abnormalities and Clinicopathological Characteristics and Disease Prognosis in Lymphoma', 'orgStudyIdInfo': {'id': 'HNCH2019341'}}, 'contactsLocationsModule': {'locations': [{'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanyan Liu, M.D. Ph.D', 'role': 'CONTACT', 'email': 'yyliu@zzu.edu.cn', 'phone': '+8613838176375'}, {'name': 'Yanyan Liu, M.D. Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Yanyan Liu, M.D. Ph.D', 'role': 'CONTACT', 'email': 'yyliu@zzu.edu.cn', 'phone': '+8613818176375'}], 'overallOfficials': [{'name': 'Yanyan Liu, M.D. Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Henan Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Yanyan Liu', 'investigatorAffiliation': 'Henan Cancer Hospital'}}}}