Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-31 @ 9:34 PM
Study NCT ID:
NCT05766332
Status:
COMPLETED
Last Update Posted:
2025-01-10
First Post:
2023-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Clinical Evaluation Tools for Predicting Risk of Complications After Hematopoietic Stem Cell Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2023-03-02', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary complication following hematopoietic stem cell transplant (HCT)', 'timeFrame': 'Up to 1 year after transplant', 'description': 'Pulmonary complications may include but are not limited to: infection, HCT-specific lung injury syndromes, acute respiratory distress syndrome, pulmonary graft versus host disease. Univariable analysis will be first used to identify potential factors that predict post-HCT pulmonary complications. All possible factors will then be included in multivariable analysis. Will also specifically test whether the six-minute walk test, grip strength and gait speed add additional significance to pulmonary complications and the statistic model after including pulmonary function test results.'}], 'secondaryOutcomes': [{'measure': '100-day mortality', 'timeFrame': 'At 100 days after transplant', 'description': 'Analyses similar to those for the primary outcome will be conducted.'}, {'measure': '1 year mortality', 'timeFrame': 'At 1 year after transplant', 'description': 'Analyses similar to those for the primary outcome will be conducted.'}, {'measure': 'Relapse-free survival', 'timeFrame': 'At 1 year after transplant', 'description': 'Analyses similar to those for the primary outcome will be conducted.'}, {'measure': 'Hospital or intensive care unit admission post-HCT', 'timeFrame': 'Up to 1 year after transplant', 'description': 'Will specifically test whether the six-minute walk test, grip strength and gait speed add additional significance to pulmonary complications and the statistic model after including pulmonary function test results.'}, {'measure': 'Need for noninvasive or invasive mechanical ventilation', 'timeFrame': 'Up to 1 year after transplant', 'description': 'Will specifically test whether the six-minute walk test, grip strength and gait speed add additional significance to pulmonary complications and the statistic model after including pulmonary function test results.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic and Lymphoid System Neoplasm', 'Malignant Solid Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates whether clinical evaluation tools such as the six-minute walk test, hand grip strength test, and gait speed test, are useful in predicting risk of complications in patients undergoing hematopoietic stem cell transplants (HCT). Being able to predict who is at increased risk of post-HCT complications can help better inform patients and providers on the risks and benefits of undergoing HCT and determine whether certain patients should have closer post-HCT monitoring due to an increased risk of complications.', 'detailedDescription': "PRIMARY OBJECTIVE:\n\nI. To develop novel pre-transplant tools for determining risk of post-HCT pulmonary complications.\n\nOUTLINE: This is an observational study.\n\nPatients undergo a clinical evaluation consisting of a six-minute walk test, hand grip strength test, and gait speed test on study. Patients' medical records are also reviewed for a year on study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing evaluation for autologous or allogeneic bone marrow transplant.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (age \\>= 18 years old)\n* Undergoing evaluation for autologous or allogeneic bone marrow transplant (HCT) at Mayo Clinic Rochester\n* Scheduled for pre-HCT pulmonary function test by the primary team\n\nExclusion Criteria:\n\n* Limited mobility requiring use of gait aid or wheelchair\n* Fall risk'}, 'identificationModule': {'nctId': 'NCT05766332', 'briefTitle': 'Evaluating Clinical Evaluation Tools for Predicting Risk of Complications After Hematopoietic Stem Cell Transplant', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Developing Novel Tools for Determining Risk of Respiratory Complications Following Hematopoietic Stem Cell Transplant', 'orgStudyIdInfo': {'id': '21-000913'}, 'secondaryIdInfos': [{'id': 'NCI-2022-01589', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '21-000913', 'type': 'OTHER', 'domain': 'Mayo Clinic in Florida'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (clinical evaluation, record review)', 'description': "Patients undergo a clinical evaluation consisting of a six-minute walk test, hand grip strength test, and gait speed test on study. Patients' medical records are also reviewed for a year on study.", 'interventionNames': ['Other: Clinical Evaluation', 'Other: Electronic Health Record Review']}], 'interventions': [{'name': 'Clinical Evaluation', 'type': 'OTHER', 'otherNames': ['Clinical Assessment'], 'description': 'Undergo clinical evaluation', 'armGroupLabels': ['Observational (clinical evaluation, record review)']}, {'name': 'Electronic Health Record Review', 'type': 'OTHER', 'description': 'Medical records reviewed', 'armGroupLabels': ['Observational (clinical evaluation, record review)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Hemang Yadav, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}