Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 5:27 PM
Study NCT ID:
NCT04545333
Status:
TERMINATED
Last Update Posted:
2024-08-01
First Post:
2020-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The clonoSEQ® Watch Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D018365', 'term': 'Neoplasm, Residual'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Remaining samples will be stored for potential use in future assay development research.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 465}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Sufficient data collected.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2020-08-31', 'studyFirstSubmitQcDate': '2020-09-03', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Average numbers of clonoSEQ Assay orders placed for enrolled lymphoid malignancy patients in routine clinical practice relative to other response assessments', 'timeFrame': 'up to 3 yrs', 'description': 'Data will be collected to determine how the clonoSEQ Assay is used as part of routine disease response assessments in lymphoid malignancy patients'}, {'measure': 'Differences in outcomes between clonoSEQ Assay MRD-negative and MRD-positive lymphoid malignancy patients', 'timeFrame': 'up to 3 yrs', 'description': 'Data will be collected to assess the following, as applicable, depending upon distribution of patients that enroll in this study:\n\n* Response to treatment, duration of response, time to next therapy, duration of maintenance therapy, and survival\n* Numbers of patients who proceed to transplant in the ALL and MM cohorts'}], 'primaryOutcomes': [{'measure': 'Distribution of timepoints at which MRD is monitored using the clonoSEQ Assay in lymphoid malignancy patients in real world settings', 'timeFrame': 'up to 3 yrs', 'description': 'Data will be collected to determine at what points lymphoid malignancy patients are in their treatment continuums when the clonoSEQ Assay is used to monitor MRD levels'}], 'secondaryOutcomes': [{'measure': 'Numbers of lymphoid malignancy patients with intensifications to their drug regimens based upon clonoSEQ MRD results', 'timeFrame': 'up to 3 yrs', 'description': 'Data will be collected with regard to changes to treatment/drug regimens in order to determine how clonoSEQ Assay MRD results inform and impact routine clinical practice'}, {'measure': 'Numbers of lymphoid malignancy patients with de-intensifications to their drug regimens based upon clonoSEQ MRD results', 'timeFrame': 'up to 3 yrs', 'description': 'Data will be collected with regard to changes to treatment/drug regimens in order to determine how clonoSEQ Assay MRD results inform and impact routine clinical practice'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Minimal residual disease', 'measurable residual disease', 'MRD', 'clonoSEQ', 'ALL', 'CLL', 'MM', 'NHL', 'Watch Registry'], 'conditions': ['Acute Lymphoblastic Leukemia, Adult B-Cell', 'Chronic Lymphocytic Leukemia', 'Multiple Myeloma', 'Non-hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter, observational study of adult patients with a diagnosis of acute lymphoblastic leukemia (ALL), multiple myeloma (MM), chronic lymphocytic leukemia (CLL), or non-Hodgkin lymphoma (NHL). This study will enroll up to 528 patients in up to 50 sites in the United States and collect data with regard to use of the clonoSEQ MRD assay in the management of lymphoid malignancies.', 'detailedDescription': "Data show that detection of MRD may be important to guide treatment decisions in ALL, MM, CLL, and NHL. However, there remains a lack of real-world evidence for making therapeutic decisions based upon MRD status. This study is designed to understand when in a patient's treatment continuum the assay is used and how clonoSEQ MRD data impact the treatment decisions made by investigators.\n\nAll patients enrolled in the study will be followed for at least 2 yrs. Demographic data and disease status will be captured at study enrollment. Patients must be \\>/= 18 yrs of age and able to sign informed consent. A given patient is eligible to enroll in the study if the treating physician has made the decision to use the clonoSEQ assay as part of that patient's routine cancer care. Reasons for placing a clonoSEQ order and subsequent decisions made as a result of MRD data will be tracked. Patient treatment will also be tracked over the course of the study in order to understand how clonoSEQ use is incorporated into current treatment regimens.\n\nParticipating centers will include sites that actively use clonoSEQ to manage their patients with lymphoid malignancies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with a diagnosis of ALL, MM, CLL, or NHL whose SOC response assessments will include monitoring of MRD status by clonoSEQ Assay', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must be able to provide written informed consent\n2. A decision has been made by the treating provider to use the clonoSEQ Assay as part of routine clinical care\n3. Age ≥ 18 years;\n4. Documented hematologic malignancy (any of the below):\n\n 1. MM\n 2. ALL (B and T-cell subtypes)\n 3. B-cell NHL (all sub types)\n 4. CLL\n 5. Other lymphoid malignancies (upon review and approval by study chair)\n\nExclusion Criteria:\n\nPatients must not meet any of the following criteria in order to be enrolled into the study:\n\n1. Concurrent enrollment in a clinical trial where treatment decisions and patterns are dictated per protocol\n2. A decision has been made by the treating provider to not use the clonoSEQ Assay as part of routine clinical care'}, 'identificationModule': {'nctId': 'NCT04545333', 'briefTitle': 'The clonoSEQ® Watch Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adaptive Biotechnologies'}, 'officialTitle': "Real World Observational Study Using clonoSEQ® Next Generation Sequencing in Hematologic Malignancies: The 'Watch' Registry", 'orgStudyIdInfo': {'id': 'ADAP-008'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ALL', 'description': 'patients diagnosed with acute lymphoblastic leukemia', 'interventionNames': ['Diagnostic Test: clonoSEQ Assay']}, {'label': 'CLL', 'description': 'patients diagnosed with chronic lymphocytic leukemia', 'interventionNames': ['Diagnostic Test: clonoSEQ Assay']}, {'label': 'MM', 'description': 'patients diagnosed with multiple myeloma', 'interventionNames': ['Diagnostic Test: clonoSEQ Assay']}, {'label': 'NHL', 'description': 'patients diagnosed with non-Hodgkin lymphoma', 'interventionNames': ['Diagnostic Test: clonoSEQ Assay']}], 'interventions': [{'name': 'clonoSEQ Assay', 'type': 'DIAGNOSTIC_TEST', 'description': 'minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells', 'armGroupLabels': ['ALL', 'CLL', 'MM', 'NHL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Hospital', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Holy Cross Hospital', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '60076', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'Edward H. Kaplan MD & Associates', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Hematology Oncology Clinic', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'American Oncology Partners of Maryland', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '63130', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novant Health', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University, Knight Cancer Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29607', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Bon Secours St Francis', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '98102', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington, Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Cancer Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Medical Specialties', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Heidi Simmons, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Adaptive Biotechnologies'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adaptive Biotechnologies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}