Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-02 @ 3:37 AM
Study NCT ID:
NCT04263857
Status:
RECRUITING
Last Update Posted:
2023-11-24
First Post:
2018-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Register of Blood Stem Cell Transplantation
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': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '20 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2037-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2018-03-02', 'studyFirstSubmitQcDate': '2020-02-10', 'lastUpdatePostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2037-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Register of stem cell transplantation', 'timeFrame': 'approximately over 20 years', 'description': 'Recording of all stem cell transplantations over many years'}], 'secondaryOutcomes': [{'measure': 'Register of toxicities', 'timeFrame': 'approximately over 20 years', 'description': 'Recording of toxicities occured during and after SCT according to GvHD Score Standards and blood and bone marrow samples, and Imaging (CT Scans)'}, {'measure': 'Register of complications', 'timeFrame': 'approximately over 20 years', 'description': 'Recording of complications occurred during and after SCT in Terms of infectious complications and occurance of GvHD (according to GvHD Score and Imaging and clinical assessment)'}, {'measure': 'Register of morbidities', 'timeFrame': 'approximately over 20 years'}, {'measure': 'Register of survivals', 'timeFrame': 'approximately over 20 years', 'description': 'Recording of survival Status, Assessment of Remission Status by bone marrow and blood diagnostics, clinical follow up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['autologous & allogenic blood stem cell transplantations'], 'conditions': ['Hematologic Malignancies']}, 'descriptionModule': {'briefSummary': 'Register of patients with blood stem cell transplantations (autologous, allogen).', 'detailedDescription': "Documenting the success rate in terms of complication rate, disease response, survival rate, engraftment, and details of transplantation settings, for example donor and conditioning data, remission status before transplantation.\n\nIt's a register of patients who have one or more autologous and / or allogenic blood stem cell transplants due to an existing indication for performing myeloablative / non-myeloablative high-dose chemotherapy.\n\nThe inclusion occurs at our center during preparation for blood stem cell transplantation. The written consent will be obtained separately in the context of the information on blood stem cell transplantation. Participation is voluntary and consent can be revoked at any time. This involves no additional effort for the patient and has no influence on his treatment. It may be necessary in the course of contacting the patient at home, as long as the data is incomplete. This is also explicitly explained. A copy of the declaration of consent is given to the patient."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all adults, Age \\>= 18 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed IC\n* patients eligible for stem cell transplantation\n\nExclusion Criteria:\n\n* unable to consent to study participation'}, 'identificationModule': {'nctId': 'NCT04263857', 'acronym': 'REBB3M', 'briefTitle': 'Register of Blood Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Register of Survey and Evaluation of Blood Stem Cell Transplantations of Clinic III of Internal Medicine III', 'orgStudyIdInfo': {'id': 'REBB3M'}}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Mareike Verbeek, MD', 'role': 'CONTACT', 'email': 'mareike.verbeek@tum.de', 'phone': '+49 89 4140', 'phoneExt': '5336'}], 'facility': 'Klinikum rechts der Isar der TU München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Mareike Verbeek, MD', 'role': 'CONTACT', 'email': 'mareike.verbeek@tum.de', 'phone': '+49 89 4140', 'phoneExt': '5336'}], 'overallOfficials': [{'name': 'Mareike Verbeek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum rechts der Isar der TU Munich, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}