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

NCT ID: NCT05766332

Last Updated: 2025-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-02

Study Completion Date

2023-11-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (clinical evaluation, record review)

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.

Clinical Evaluation

Intervention Type OTHER

Undergo clinical evaluation

Electronic Health Record Review

Intervention Type OTHER

Medical records reviewed

Interventions

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Clinical Evaluation

Undergo clinical evaluation

Intervention Type OTHER

Electronic Health Record Review

Medical records reviewed

Intervention Type OTHER

Other Intervention Names

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Clinical Assessment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hemang Yadav, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2022-01589

Identifier Type: REGISTRY

Identifier Source: secondary_id

21-000913

Identifier Type: OTHER

Identifier Source: secondary_id

21-000913

Identifier Type: -

Identifier Source: org_study_id

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