Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-01-01 @ 8:50 AM
Study NCT ID:
NCT06394895
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2023-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Donor Neutrophil Subsets to Predict the Risk of aGVHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}, 'targetDuration': '100 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-06-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-28', 'studyFirstSubmitDate': '2023-12-20', 'studyFirstSubmitQcDate': '2024-04-28', 'lastUpdatePostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between donor neutrophil subsets and acute graft-vs.-host disease (aGVHD) outcomes.', 'timeFrame': '100days'}], 'secondaryOutcomes': [{'measure': 'Association between donor neutrophil subsets and chronic GVHD (cGVHD)', 'timeFrame': '6 months'}, {'measure': 'Association between donor neutrophil subsets and leukemia relapse', 'timeFrame': '6 months'}, {'measure': 'Association between donor neutrophil subsets and non-relapse mortality (NRM)', 'timeFrame': '6 months'}, {'measure': 'Association between donor neutrophil subsets and disease-free survival (DFS)', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Graft-versus-Host Disease']}, 'descriptionModule': {'briefSummary': 'This is a prospective study to explore the association between donor neutrophil subsets and acute graft-vs.-host disease outcomes. Approximately 260 subjects (including 130 donors and 130 corresponding recipients) will be recruited.', 'detailedDescription': 'This study was a single-center, observational, prospective cohort study. The study lasted for 3 months, from 2023.12 to 2024.3, the clinical enrollment was completed, and from 2024.3 to 2024.6, the follow-up was completed. It is planned to enroll 260 subjects, divided into 130 donors and 130 patients.\n\nNo randomization or any protocol-driven treatment will be performed or provided to subjects during the course of the study. Treatment decisions and selection of treatment options are left to the discretion of the treating physician, if clinically appropriate.\n\nAll recipients will be followed for aGVHD evaluation, relapse, cGVHD, leukemia relapse, disease-free survival (DFS), non-relapse mortality (NRM). aGVHD and cGVHD were graded according to published guidelines. All recipients will be monitored every month until the study is completed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients following allogeneic hematopoietic stem cell transplantation and the corresponding donors', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDonors\n\n1. Voluntarily sign the informed consent form;\n2. Age 16-65 years old\n3. Donors whose HLA-matched or HLA-mismatched to the corresponding recipients\n\nRecipients\n\n1. Voluntarily sign the informed consent form\n2. Age 16-65 years old\n3. Willing to undergo HLA-matched or HLA-mismatched allo-HSCT\n\nExclusion Criteria:\n\nDonors\n\n1. Have a history of other tumors\n2. With poor compliance or mental disorders\n3. Infected with HIV and HCV\n4. With uncontrolled HBV infection\n5. With other autoimmune diseases\n6. Those who are judged by the researcher to be unsuitable to participate in this study\n\nRecipients\n\n1. Have a history of other tumors\n2. With poor compliance or mental disorders\n3. Infected with HIV and HCV\n4. With uncontrolled HBV infection\n5. With other autoimmune diseases\n6. Those who are judged by the researcher to be unsuitable to participate in this study'}, 'identificationModule': {'nctId': 'NCT06394895', 'briefTitle': 'Donor Neutrophil Subsets to Predict the Risk of aGVHD', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Donor Neutrophil Subsets to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'NFEC-2023-500'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subject-recipient (high incidence /low incidence group)'}, {'label': 'Subject-donor'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Other (Non U.s.)', 'country': 'China', 'facility': 'Nanfang Hospital, Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Hua Jin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}