Parametric Response Mapping (PRM) for the Detection of Chronic Lung Injury in Hematopoietic Cell Transplant Recipients
36 Months and older, Male and Female
UMCC 2022.052 (primary)
NCI-2023-05585
HUM00225273
Summary
This study is being done to detect and diagnose graft versus host disease (GVHD) of the lungs (termed “lung GVHD”) following a bone marrow or stem cell transplant. Chronic GVHD is a common problem after transplant and if successful, this study may offer patients a new way (called parametric response mapping) to identify lung GVHD.
Objectives
PRIMARY OBJECTIVES:
I. To correlate PRM profiles (PRMfSAD, PRMPD) at the onset of chronic GVHD with subsequent progression to CLD over a 12-month period. (Cohort I)
II. To evaluate PRM as a predictor of “lung function decline” in patients with an established diagnosis of CLD. (Cohort II)
OUTLINE: This is an observational study.
Patients undergo computed tomography (CT), complete pulmonary function tests, and undergo blood sample collection on study. Patients' medical records are reviewed.
Eligibility
- FOR COHORTS I AND II:
* 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 I:
* 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
- COHORT II:
* 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)
*** FEV1 < 75% predicted, with a decline in absolute FEV1 > 10% compared to pretransplant baseline or within the prior 2 years.
*** FEV1/VC or FEV1/FVC < 0.7
*** 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.
*** One of two supportive features of BOS:
**** Evidence of air trapping by PFTs: RV > 120%, or elevated RV/TLC (> 20% of predicted)
**** 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):
*** >= 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.
*** 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
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