Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-01-05 @ 1:56 AM
Study NCT ID:
NCT05676450
Status:
RECRUITING
Last Update Posted:
2025-10-31
First Post:
2022-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Clinical Utility of Cell-free DNA (cfDNA) in Identifying Actionable Alterations and Minimal Residual Disease for Lymphoma Patients Across Community Centers in Texas
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000081182', 'term': 'Noninvasive Prenatal Testing'}], 'ancestors': [{'id': 'D000073890', 'term': 'Liquid Biopsy'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D005820', 'term': 'Genetic Testing'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D011296', 'term': 'Prenatal Diagnosis'}, {'id': 'D003944', 'term': 'Diagnostic Techniques, Obstetrical and Gynecological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 517}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2022-12-15', 'studyFirstSubmitQcDate': '2022-12-22', 'lastUpdatePostDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'through study completion; an average 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To test the feasibility of collecting cell-free DNA (cfDNA) samples from DLBCL patients before and after treatment. cfDNA is DNA traveling in your blood outside of a cell and is easily collected from blood samples drawn using the vein puncture method.', 'detailedDescription': 'Primary Objective:\n\n• To determine the feasibility and clinical utility of ctDNA in identifying actionable alterations and minimal residual disease for lymphoma patients across community centers in Texas.\n\nSecondary Objectives:\n\n* To provide useful prognostic information before treatment, assess molecular response at interim time points and residual disease at the end of therapy, and identify tumor-specific mutations\n* Levels of cfDNA and its association with both EFS and OS in patients receiving therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male/female patients who are at least 18 years of age on the day of informed consent signing.\n2. Patients must have a histologically documented diffuse large B-cell lymphoma requiring therapy.\n3. Provision of written informed consent for the study.\n4. Pregnant women not included\n5. Cognitively impaired adults are not included.\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT05676450', 'briefTitle': 'Feasibility and Clinical Utility of Cell-free DNA (cfDNA) in Identifying Actionable Alterations and Minimal Residual Disease for Lymphoma Patients Across Community Centers in Texas', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Feasibility and Clinical Utility of Cell-free DNA (cfDNA) in Identifying Actionable Alterations and Minimal Residual Disease for Lymphoma Patients Across Community Centers in Texas', 'orgStudyIdInfo': {'id': '2022-0603'}, 'secondaryIdInfos': [{'id': 'NCI-2022-10562', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Trials Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'cell-free DNA (cfDNA) samples', 'description': 'cell-free DNA (cfDNA) samples from DLBCL participants before and after treatment. cfDNA is DNA traveling in your blood outside of a cell and is easily collected from blood samples drawn using the vein puncture method.\n\nBlood will be drawn 3 times (by vein)', 'interventionNames': ['Diagnostic Test: cell-free DNA']}], 'interventions': [{'name': 'cell-free DNA', 'type': 'DIAGNOSTIC_TEST', 'description': 'Given by IV (vein)', 'armGroupLabels': ['cell-free DNA (cfDNA) samples']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chijioke Nze, MD', 'role': 'CONTACT', 'email': 'CCNze@mdanderson.org', 'phone': '832-729-1752'}, {'name': 'Chijioke Nze, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adolfo Enriques Diaz Duque, MD', 'role': 'CONTACT', 'email': 'diazduque@uthscsa.edu', 'phone': '210-450-1209'}, {'name': 'Adolfo Enriques Diaz Duque, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Therapy and Research Center at The UT Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Chijioke Nze, MD', 'role': 'CONTACT', 'email': 'CCNze@mdanderson.org', 'phone': '832-729-1752'}], 'overallOfficials': [{'name': 'Chijioke Nze, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}