Hematopoietic and Lymphoid System NeoplasmNCT05766332
Evaluating Clinical Evaluation Tools for Predicting Risk of Complications After Hematopoietic Stem Cell Transplant
An observational study of Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Clinical Evaluation and Electronic Health Record Review
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2021to 17 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing evaluation for autologous or allogeneic bone marrow transplant.
Who may be able to join
- 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
Who cannot join
- Limited mobility requiring use of gait aid or wheelchair
- Fall risk
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Developing Novel Tools for Determining Risk of Respiratory Complications Following Hematopoietic Stem Cell Transplant
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Being tested
- Clinical Evaluation, Electronic Health Record Review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical EvaluationOther
Also called Clinical Assessment
Undergo clinical evaluation
Electronic Health Record ReviewOther
Medical records reviewed
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Clinical Evaluation; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year after transplant
Secondary outcomes (5)
100-day mortality
Analyses similar to those for the primary outcome will be conducted.
Measured: At 100 days after transplant
1 year mortality
Analyses similar to those for the primary outcome will be conducted.
Measured: At 1 year after transplant
Relapse-free survival
Analyses similar to those for the primary outcome will be conducted.
Measured: At 1 year after transplant
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.
Measured: Up to 1 year after transplant
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.
Measured: Up to 1 year after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start2 Aug 2021
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hemang Yadav, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766332
- Sponsor's protocol ID
- 21-000913
- Other IDs
- NCI-2022-01589, 21-000913
- Status last verified
- Jan 2025
- First submitted
- 22 Feb 2023
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Novel Tools for Determining Risk of Respiratory Complications Following Hematopoietic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT05766332
- Acronym / sponsor ID
- 21-000913
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVE:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (clinical evaluation, record review) | – | Other: Clinical Evaluation, Other: Electronic Health Record ReviewPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing evaluation for autologous or allogeneic bone marrow transplant.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Limited mobility requiring use of gait aid or wheelchair
- Fall risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical EvaluationAlso: Clinical AssessmentUndergo clinical evaluation | Other | Observational (clinical evaluation, record review) |
| Electronic Health Record ReviewMedical records reviewed | Other | Observational (clinical evaluation, record review) |
Primary outcome
Pulmonary complication following hematopoietic stem cell transplant (HCT)
Time frame: Up to 1 year after transplant
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.
5 secondary outcomes
100-day mortality
Time frame: At 100 days after transplant
1 year mortality
Time frame: At 1 year after transplant
Relapse-free survival
Time frame: At 1 year after transplant
Hospital or intensive care unit admission post-HCT
Time frame: Up to 1 year after transplant
Need for noninvasive or invasive mechanical ventilation
Time frame: Up to 1 year after transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hemang Yadav, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary complication following hematopoietic stem cell transplant (HCT) (time frame: Up to 1 year after transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.