Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
Study NCT ID:
NCT06564259
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2024-08-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relationship Between Serum β2-Microglobulin and Infiltration of CD8+ in the Tumor Tissue of Hodgkin's Lymphoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'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 lymph nodes embedded in paraffin'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-18', 'studyFirstSubmitDate': '2024-08-18', 'studyFirstSubmitQcDate': '2024-08-18', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Therapeutic response', 'timeFrame': '2-4 months', 'description': 'Achieving complete remission after chemotherapy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['serum Beta-2 Microglobulin, CD8+ cells, Hodgkin lymphoma, Predictive value, Chemotherapy.'], 'conditions': ['Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'In newly diagnosed Hodgkin lymphoma patients, pre-treatment Beta-2 Microglobulin (B2M) levels will be measured. A thorough baseline assessment will be performed using CT imaging, and tumor tissue samples will be collected for Immunohistochemical (IHC) analysis to quantify CD8+ cell infiltration. Patients will be closely monitored throughout their treatment, with a follow-up CT scan at the end of therapy to evaluate therapeutic response. This study aims to investigate the correlation between pre-treatment B2M levels and CD8+ immune cell infiltration in tumor tissues, assessing their potential as predictive markers for chemotherapy response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study included a cohort of 144 patients newly diagnosed with Hodgkin lymphoma. Patients were between the ages of 14 and 71 years, with an almost balanced representation of both genders. All participants had a confirmed Hodgkin lymphoma diagnosis based on histopathological examination. The study population reflected a diverse range of disease stages and subtypes, providing a comprehensive understanding of the relationship between pre-treatment Beta-2 Microglobulin (B2M) levels, CD8+ cell infiltration, and chemotherapy response in this patient population.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed patients with Hodgkin lymphoma\n* No prior history of malignancy\n* Absence of primary or secondary immunodeficiencies\n\nExclusion Criteria:\n\n* Patients who have previously undergone treatment\n* Patients with acute or chronic infections\n* Patients with renal disorders\n* Individuals with autoimmune diseases\n* HIV-positive patients'}, 'identificationModule': {'nctId': 'NCT06564259', 'briefTitle': "Relationship Between Serum β2-Microglobulin and Infiltration of CD8+ in the Tumor Tissue of Hodgkin's Lymphoma Patients", 'organization': {'class': 'OTHER', 'fullName': 'Tishreen University'}, 'officialTitle': 'The Relationship Between Serum Beta-2 Microglobulin (sB2M) Levels and CD8+ Cell Infiltration in Hodgkin Lymphoma Tissues: Impact on Chemotherapy Outcomes', 'orgStudyIdInfo': {'id': '1839'}}, 'contactsLocationsModule': {'locations': [{'city': 'Latakia', 'country': 'Syria', 'facility': 'Tishreen University', 'geoPoint': {'lat': 35.53125, 'lon': 35.79088}}], 'overallOfficials': [{'name': 'Firas Hussien, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Tishreen University'}, {'name': 'Maram Bilal, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tishreen University'}, {'name': 'Hasan Khalil, Ms', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tishreen University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tishreen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}