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NCT05766332 Clinical Trial

Evaluating Clinical Evaluation Tools for Predicting Risk of Complications After Hematopoietic Stem Cell Transplant

Malignant Solid Neoplasm Clinical Trial

Official title:
Developing Novel Tools for Determining Risk of Respiratory Complications Following Hematopoietic Stem Cell Transplant

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05766332
Other study ID # 21-000913
Secondary ID NCI-2022-0158921
Status Recruiting
Phase
First received
Last updated
Start date July 19, 2021
Est. completion date August 2025

Study information
Verified date February 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

PRIMARY OBJECTIVE: I. To develop novel pre-transplant tools for determining risk of post-HCT pulmonary complications. OUTLINE: This is an observational study. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date August 2025
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients (age >= 18 years old) - Undergoing evaluation for autologous or allogeneic bone marrow transplant (HCT) at Mayo Clinic Rochester - Scheduled for pre-HCT pulmonary function test by the primary team Exclusion Criteria: - Limited mobility requiring use of gait aid or wheelchair - Fall risk

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Clinical Evaluation
Undergo clinical evaluation
• Electronic Health Record Review
Medical records reviewed

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pulmonary complication following hematopoietic stem cell transplant (HCT) 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. Up to 1 year after transplant
Secondary 100-day mortality Analyses similar to those for the primary outcome will be conducted. At 100 days after transplant
Secondary 1 year mortality Analyses similar to those for the primary outcome will be conducted. At 1 year after transplant
Secondary Relapse-free survival Analyses similar to those for the primary outcome will be conducted. At 1 year after transplant
Secondary Hospital or intensive care unit admission post-HCT 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. Up to 1 year after transplant
Secondary Need for noninvasive or invasive mechanical ventilation 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. Up to 1 year after transplant
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