Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-04-15 @ 11:19 PM
Study NCT ID:
NCT04806295
Status:
RECRUITING
Last Update Posted:
2022-04-07
First Post:
2021-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Leukemia and Lymphoma Society (LLS) National Research Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2027-07-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-05', 'studyFirstSubmitDate': '2021-03-16', 'studyFirstSubmitQcDate': '2021-03-16', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LLS will monitor outcomes of people being treated for blood cancer.', 'timeFrame': '10 years', 'description': '. The LLS National Research Registry will collect data on up to 1000 research subjects, over up to 10 years, storing that data, including protected health information (PHI) and images, in secure databases, and share de-identified summary data with research partners (like academic researchers, advocacy groups, and pharmaceutical companies) that are advancing treatments for blood cancer. Participation in The LLS National Research Registry may not give research subjects any immediate benefit. It is hoped the knowledge gained from data collected in The LLS National Research Registry will benefit people with blood cancers in the future using this information for research purposes, directed at blood cancers and associated comorbidities.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blood Cancer']}, 'descriptionModule': {'briefSummary': 'The Leukemia and Lymphoma Society (LLS) has built a National Research Registry to evaluate real world experiences and medical outcomes for people with blood cancer, before, during, and after blood cancer treatments.', 'detailedDescription': 'The LLS National Research Registry is a real-world experiences and outcomes research registry; a collection of patient information and medical data, over time, about people who have a particular disease or condition, or who receive a particular treatment.\n\nThe LLS National Research Registry Protocol will:\n\n1. Answer research questions using data collected from people with blood cancers. Such research involves analyses of subject profile information completed by subjects and medical records data.\n2. Obtain permission from LLS National Research Registry research subjects to have Ciitizen, a third-party engaged by LLS, act as their proxy to retrieve full medical record data including images at no cost to research subjects. Note: Patient can choose to upload their medical records into their account, directly.\n3. Obtain permission from LLS National Research Registry research subjects to share summary data with research partners (like academic researchers, advocacy groups, and pharmaceutical companies) that are advancing treatments for blood cancer. "Summary data" represents the important elements of medical record data, coded for research use, with personal identifiers like name, address, and phone number removed.\n4. Obtain permission from LLS National Research Registry research subjects to be contacted from time to time, for them to provide updated medical information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People with blood cancer, before, during, and after blood cancer treatments.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPeople with blood cancer, before, during, and after blood cancer treatments.\n\nExclusion Criteria:\n\nPeople unable or unwilling to sign informed consent.'}, 'identificationModule': {'nctId': 'NCT04806295', 'briefTitle': 'The Leukemia and Lymphoma Society (LLS) National Research Registry', 'organization': {'class': 'OTHER', 'fullName': 'Lymphoma and Leukemia Society'}, 'officialTitle': 'The Leukemia and Lymphoma Society (LLS) National Research Registry', 'orgStudyIdInfo': {'id': 'LLSNRR-17-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'any/all treatments for blood cancer', 'type': 'OTHER', 'description': 'Following people undergoing any/all treatments for blood cancer.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10573', 'city': 'Rye Brook', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Larry Saltzman, MD', 'role': 'CONTACT', 'email': 'larry.saltzman@lls.org', 'phone': '844-696-7228'}, {'name': 'Brian J Chadwick, BS RN', 'role': 'CONTACT', 'email': 'chadwickbj@gmail.com', 'phone': '9144145788'}], 'facility': 'Lymphoma and Leukemia Society', 'geoPoint': {'lat': 41.01926, 'lon': -73.68346}}], 'centralContacts': [{'name': 'Larry Saltzman, MD', 'role': 'CONTACT', 'email': 'larry.saltzman@lls.org', 'phone': '844-696-7228'}, {'name': 'Brian J Chadwick, BS RN', 'role': 'CONTACT', 'email': 'chadwickbj@gmail.com', 'phone': '9144145788'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'As data is collected, de-identified and stored in a secure database, it will be provided over time to LLS investigators and investigators approved by LLS.', 'ipdSharing': 'YES', 'description': 'Participating subjects will be asked to provide permission to share de-identified summary data with research partners (like academic researchers, advocacy groups, and pharmaceutical companies) that are advancing treatments for cancer, neurological disorders, and other diseases. "Summary data" represents the important elements of medical record data, coded for research use, with personal identifiers like name, address, and phone number removed.', 'accessCriteria': 'De-identified data will be made available to LLS investigators and investigators approved by LLS.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lymphoma and Leukemia Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}