Chronic Lung DiseaseNCT05866302
Parametric Response Mapping (PRM) for the Detection of Chronic Lung Injury in Hematopoietic Cell Transplant Recipients
An observational study of Chronic Lung Disease and Hematopoietic Cell Transplantation, run by University of Michigan Rogel Cancer Center at 6 sites in United States.
Trial summary
The study will have two separate patient cohorts: Cohort 1 will include patients with newly diagnosed chronic graft versus host disease (GVHD), whereas cohort 2 will include patients with newly diagnosed chronic lung disease (CLD). Read more about this study
- Who is it for?
- Ages 36 months and older
- Conditions the study is for
- Chronic Lung Disease, Hematopoietic Cell Transplantation, Graft Versus Host Disease
- How many people
- 375 participants
- Where
- 6 sitesUnited States
- Study dates
- 30 May 2023to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 36 months and older
- All sexes
- Child, Adult, Older adult
Study population: Pediatric and adult HCT populations
Who may be able to join
- For both Cohorts 1 and 2:
- Age ≥ 36 months. There is no upper age limit.
- Receipt of an allogeneic HCT. There are no exclusions to study entry based upon primary diagnosis, hematopoietic cell source, conditioning regimen, donor type, degree of donor-recipient HLA match, or current organ function.
- All patients and/or their parents or legal guardians must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
- Cohort 1 (Chronic Graft Versus Host Disease): Diagnosis of chronic GVHD in at least 1 organ system within the prior 3 months. NIH Consensus Criteria for chronic GVHD are required to establish the diagnosis. (https://pubmed.ncbi.nlm.nih.gov/25529383/)
- Cohort 2 (Chronic Lung Disease, CLD) Diagnosis of CLD within the prior 100 days, including either Bronchiolitis Obliterans Syndrome (BOS) or Restrictive lung disease (RLD), with each defined as follows: Bronchiolitis Obliterans Syndrome (BOS): (NIH Consensus Criteria)31 a.FEV1 < 75% predicted, with a decline in absolute FEV1 > 10% compared to pretransplant baseline or within the prior 2 years, b.FEV1/VC or FEV1/FVC < 0.7 , c. Absence of an alternative diagnosis, including COPD exacerbation, asthma, and active respiratory tract infection, as determined by appropriate clinical investigations that may include chest imaging, microbiologic cultures, and/or bronchoscopy, d. One of two supportive features of BOS: i. Evidence of air trapping by PFTs: RV>120%, or elevated RV/TLC (>20% of predicted), ii. High resolution chest CT with inspiratory and expiratory cuts that show findings that are consistent with small airways disease including (but not exclusive of) air trapping, bronchial wall thickening, or bronchiectasis. Restrictive Lung Disease (RLD): a. ≥ 20% decline in FEV1 from baseline, coupled with ≥ 10% decline in total lung capacity (TLC) from baseline. If measurements of TLC are not available, then a ≥ 20% decline in FVC from baseline may be substituted for RLD.32, b.Radiographic opacities or infiltrates on chest radiograph or CT. Such changes may include, but are not limited to the presence of ground glass opacities, reticular changes, septal thickening, fibrotic changes or areas of consolidation.
- Patients unable to perform PFT. For cohort 1, patient's too young (or physically unable) to perform PFT's remain eligible provided they meet all other eligibility criteria. For cohort 2, children too young (or physically unable) to perform PFT's are eligible provided they exhibit both clinical and radiographic features (on CT) consistent with CLD. Clinical features would include dyspnea, cough, and/or SpO2 < 93% on room air. Radiographic features may include, but are not limited to the presence of air trapping, bronchial wall thickening, or bronchiectasis.
Who cannot join
- Relapse of a patient's primary malignancy post-HCT, or the development of any secondary "hematologic" malignancy post-HCT.
- The presence of an active, uncontrolled infection.
- Patients who would require intubation solely for the purposes of obtaining a CT scan for PRM imaging. (In contrast, if a clinical CT is being performed as routine medical care to evaluate a patient's lung function, the patient is eligible and PRM imaging may be performed from that CT.)
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
The University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
Cancer AnswerLine, 800-865-1125
Cancer AnswerLine, 1-800-865-1125
- Not yet recruiting
Emory University
Atlanta, Georgia, 30322
Kirsten Williams, kirsten.marie.williams@emory.edu
Kirsten Williams
- Not yet recruiting
Dana Farber
Boston, Massachusetts, 02215
Christine Duncan, chrisin_Duncan@dfci.harvard.edu
Christine Duncan
- Not yet recruiting
MD Anderson
Houston, Texas, 77030
Ajay Sheshadri, Asheshadri@mdanderson.org
Ajay Sheshadri
- Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Guan-Shing Cheng, gcheng2@fredhutch.org
Guang-Shing Cheng
- Recruiting
Stanford Hospital
Stanford, California, 94305
Joe Hsu, joehsu@stanford.edu
Joe Hsu
About this study
Official title: Parametric Response Mapping (PRM) for the Detection of Chronic Lung Injury in Hematopoietic Cell Transplant Recipients. A Multi-center, Observational Trial.
The study will have two separate patient cohorts: Cohort 1 will include patients with newly diagnosed chronic graft versus host disease (GVHD), whereas cohort 2 will include patients with newly diagnosed chronic lung disease (CLD). For cohort 1, the primary objective will be to characterize PRM metrics at the onset of chronic GVHD and determine if a PRM signature is present that will predict 1-year CLD free survival. For cohort 2, the primary objective will focus on characterizing PRM at the onset of CLD and determine if PRM can predict the trajectory in lung function decline in affected patients.
- Keywords
- Parametric response mapping
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Newly diagnosed chronic GVHD | All subjects will undergo a non-contrast, high resolution CT scan with inspiratory and expiratory imaging, pulmonary function testing (PFT) and serologic biomarker studies upon entry. A total of 300 subjects (200 adults, 100 pediatric) will be enrolled. Patients in cohort 1 who develop CLD prior to the 12-month period will transition to cohort 2 at that time. PFT is recommended every 3 months over a 12 month period. Plasma samples will be collected at entry and at 12 months. | |
| Cohort 2: Newly diagnosed chronic lung disease (CLD) | All subjects will undergo a non-contrast, high resolution CT scan with inspiratory and expiratory imaging, pulmonary function testing (PFT) and serologic biomarker studies upon entry. A total of 75 subjects (50 adults, 25 pediatric) will be enrolled. PFT is recommended every 3 months over a 12 month period. Plasma samples will be collected at entry and at 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year CLD free survival (Cohort 1)
The time to develop CLD or death over 12 months of follow-up in both pediatric and adult subjects will be determined. we will classify subjects into comparison groups of (1) high PRMfSAD (>30%), (2) high PRMPD (>40%) or (3) neither high PRMfSAD nor high PRMPD (PRMNorm group). The two primary analyses are to compare 1-year CLD-free survival between the high PRMfSAD and PRMNorm groups and separately between the high PRMPD and PRMNorm groups, using two-sided, two-sample logrank tests with an overall 5% type I error, adjusted for 2 comparisons using the Bonferroni method
Measured: up to 12 months from enrollment
FEV1 decline (Cohort 2)
Trajectory of FEV1 decline over a 12-month period in patients with newly diagnosed CLD. To evaluate PRM as a predictor of "lung function decline" in patients with an established diagnosis of CLD.
Measured: up to 12 months from enrollment
Secondary outcomes (4)
PRM profiles in children at the onset of chronic GVHD (Cohort 1)
Pediatric subjects will be enrolled into one of 2 strata (PFT+ vs PFTnull), PRM imaging with whole lung volumetric CT scans will be performed at baseline, using low dose CT techniques in children. Strata 1 (PFT+), the occurrence of CLD will be defined using NIH Consensus Criteria for BOS, or ISHLT criteria for RLD. Stratum 2 (PFTnull), radiographic findings of obstructive or restrictive lung disease on CT, plus clinical symptoms (dyspnea, or hypoxia) will be required to establish a diagnosis of CLD, in lieu of PFTs. PRM profile will be reported as percent functional small airway disease (PRMfSAD), emphysema (PRMEmph), parenchymal lung disease (PRMPD), and normal lung parenchyma (PRMNorm), in relation to the total lung volume.
Measured: up to 12 months from enrollment
Correlate PRM profiles at the onset of chronic GVHD with overall survival post-HCT (Cohort 1)
Subjects will be enrolled into one of 2 strata (PFT+ vs PFTnull), PRM imaging with whole lung volumetric CT scans will be performed at baseline.. For patients in strata 1 (PFT+), the occurrence of CLD will be defined using NIH Consensus Criteria for BOS, or ISHLT criteria for RLD. For patients in stratum 2 (PFTnull), radiographic findings of obstructive or restrictive lung disease (i.e. air trapping, bronchiectactic changes, interstitial fibrosis) on CT, plus clinical symptoms (dyspnea, or hypoxia) will be required to establish a diagnosis of CLD, in lieu of PFTs. Histograms of PRMfSAD, PRMPD, PRMEmph, and PRMNorm values will be displayed by pediatric stratum and overall, with means ± standard errors superimposed on the plots. PRM profile will be reported as percent functional small airway disease (PRMfSAD), emphysema (PRMEmph), parenchymal lung disease (PRMPD), and normal lung parenchyma (PRMNorm), in relation to the total lung volume.
Measured: up to 12 months from enrollment
To characterize a PRM profile for CLD in children post-HCT (Cohort 2)
We will have approximately 90% power to detect correlations > 0.47 using 2-sided 1-sample correlation tests. This is a conservative estimate involving only the adult participants, with power increasing once pediatric participants are included in the analysis. In a secondary analysis we will use linear mixed effects models to study FEV1 predicted trajectories after CLD onset, as a function of PRM values. We will explore interactions between PRM values and time post-CLD when modeling FEV1 predicted values over time. PRM profile will be reported as percent functional small airway disease (PRMfSAD), emphysema (PRMEmph), parenchymal lung disease (PRMPD), and normal lung parenchyma (PRMNorm), in relation to the total lung volume.
Measured: up to 12 months from enrollment
To determine a PRM profile for restrictive lung disease (RLD) in adults with chronic GVHD post-HCT (Cohort 2)
We will have approximately 90% power to detect correlations > 0.47 using 2-sided 1-sample correlation tests. This is a conservative estimate involving only the adult participants, with power increasing once pediatric participants are included in the analysis. In a secondary analysis we will use linear mixed effects models to study FEV1 predicted trajectories after CLD onset, as a function of PRM values. We will explore interactions between PRM values and time post-CLD when modeling FEV1 predicted values over time. PRM profile will be reported as percent functional small airway disease (PRMfSAD), emphysema (PRMEmph), parenchymal lung disease (PRMPD), and normal lung parenchyma (PRMNorm), in relation to the total lung volume.
Measured: up to 12 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start30 May 2023
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lung DiseaseStudies of the same condition, open and under way.
- 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
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Gregory Yanik, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866302
- Sponsor's protocol ID
- UMCC 2022.052
- Other IDs
- HUM00225273, R01HL162661
- Status last verified
- Oct 2025
- First submitted
- 13 Apr 2023
- Last updated
- 20 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parametric Response Mapping (PRM) for the Detection of Chronic Lung Injury in Hematopoietic Cell Transplant Recipients. A Multi-center, Observational Trial.
- ClinicalTrials.gov ID
- NCT05866302
- Acronym / sponsor ID
- UMCC 2022.052
- Keywords
- Parametric response mapping
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 30 May 2023 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 19 May 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.
The study will have two separate patient cohorts: Cohort 1 will include patients with newly diagnosed chronic graft versus host disease (GVHD), whereas cohort 2 will include patients with newly diagnosed chronic lung disease (CLD). For cohort 1, the primary objective will be to characterize PRM metrics at the onset of chronic GVHD and determine if a PRM signature is present that will predict 1-year CLD free survival. For cohort 2, the primary objective will focus on characterizing PRM at the onset of CLD and determine if PRM can predict the trajectory in lung function decline in affected patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Newly diagnosed chronic GVHD | – | –All subjects will undergo a non-contrast, high resolution CT scan with inspiratory and expiratory imaging, pulmonary function testing (PFT) and serologic biomarker studies upon entry. A total of 300 subjects (200 adults, 100 pediatric) will be enrolled. Patients in cohort 1 who develop CLD prior to the 12-month period will transition to cohort 2 at that time. PFT is recommended every 3 months over a 12 month period. Plasma samples will be collected at entry and at 12 months. |
| Cohort 2: Newly diagnosed chronic lung disease (CLD) | – | –All subjects will undergo a non-contrast, high resolution CT scan with inspiratory and expiratory imaging, pulmonary function testing (PFT) and serologic biomarker studies upon entry. A total of 75 subjects (50 adults, 25 pediatric) will be enrolled. PFT is recommended every 3 months over a 12 month period. Plasma samples will be collected at entry and at 12 months. |
Who may qualify
- Ages
- 36 months and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and adult HCT populations
Key inclusion criteria (7 listed)
- For both Cohorts 1 and 2:
- Age ≥ 36 months. There is no upper age limit.
- Receipt of an allogeneic HCT. There are no exclusions to study entry based upon primary diagnosis, hematopoietic cell source, conditioning regimen, donor type, degree of donor-recipient HLA match, or current organ function.
- All patients and/or their parents or legal guardians must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
- Cohort 1 (Chronic Graft Versus Host Disease): Diagnosis of chronic GVHD in at least 1 organ system within the prior 3 months. NIH Consensus Criteria for chronic GVHD are required to establish the diagnosis. (https://pubmed.ncbi.nlm.nih.gov/25529383/)
Key exclusion criteria (3 listed)
- Relapse of a patient's primary malignancy post-HCT, or the development of any secondary "hematologic" malignancy post-HCT.
- The presence of an active, uncontrolled infection.
- Patients who would require intubation solely for the purposes of obtaining a CT scan for PRM imaging. (In contrast, if a clinical CT is being performed as routine medical care to evaluate a patient's lung function, the patient is eligible and PRM imaging may be performed from that CT.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1-year CLD free survival (Cohort 1)
Time frame: up to 12 months from enrollment
The time to develop CLD or death over 12 months of follow-up in both pediatric and adult subjects will be determined. we will classify subjects into comparison groups of (1) high PRMfSAD (>30%), (2) high PRMPD (>40%) or (3) neither high PRMfSAD nor high PRMPD (PRMNorm group). The two primary analyses are to compare 1-year CLD-free survival between the high PRMfSAD and PRMNorm groups and separately between the high PRMPD and PRMNorm groups, using two-sided, two-sample logrank tests with an overall 5% type I error, adjusted for 2 comparisons using the Bonferroni method
FEV1 decline (Cohort 2)
Time frame: up to 12 months from enrollment
Trajectory of FEV1 decline over a 12-month period in patients with newly diagnosed CLD. To evaluate PRM as a predictor of "lung function decline" in patients with an established diagnosis of CLD.
4 secondary outcomes
PRM profiles in children at the onset of chronic GVHD (Cohort 1)
Time frame: up to 12 months from enrollment
Correlate PRM profiles at the onset of chronic GVHD with overall survival post-HCT (Cohort 1)
Time frame: up to 12 months from enrollment
To characterize a PRM profile for CLD in children post-HCT (Cohort 2)
Time frame: up to 12 months from enrollment
To determine a PRM profile for restrictive lung disease (RLD) in adults with chronic GVHD post-HCT (Cohort 2)
Time frame: up to 12 months from enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Gregory Yanik, MD principal investigator
University of Michigan
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lung Disease and Hematopoietic Cell Transplantation, run by University of Michigan Rogel Cancer Center at 6 sites 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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Answerline (1-800-865-1125, CancerAnswerLine@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year CLD free survival (Cohort 1) (time frame: up to 12 months from enrollment). The study lists 2 primary outcomes in all. 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 20 Oct 2025.