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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-01242 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 10360 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| R01CA118953 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial collects clinical data and blood samples to predict the quality of response to specific treatments in patients with chronic graft-versus-host disease (cGVHD) who are about to start a new therapy. Collecting and analyzing clinical data and blood samples from patients with cGVHD before and after treatment initiation may help doctors identify changes that may predict treatment response.
OUTLINE: This is an observational study.
Patients complete questionnaires over 10 minutes about physical symptoms, activity level, and emotional well-being and have their medical records reviewed at baseline, 1, 3, and 6 months after starting index treatment, and at start of a new systemic treatment. Patients also undergo collection of blood samples over 1-2 minutes at baseline and at 1 month after starting index treatment, or at a treatment change visit if new therapy has not started.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (questionnaire, biospecimen, chart review) | Patients complete questionnaires over 10 minutes about physical symptoms, activity level, and emotional well-being and have their medical records reviewed at baseline, 1, 3, and 6 months after starting index treatment, and at start of a new systemic treatment. Patients also undergo collection of blood samples over 1-2 minutes at baseline and at 1 month after starting index treatment, or at a treatment change visit if new therapy has not started. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood sample |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response according to the 2014 criteria | At the assessments, the 9 provider-reported National Institute of Health (NIH) organ severity scores (skin, eye, mouth, esophagus, upper gastrointestinal [GI], lower GI, liver, lung, and joint manifestations) will be collected reflecting disease activity in the past week. All scored items are single 4-7 point Likert scales. Based on past work, we anticipate it will take approximately 8 minutes to conduct the physical exam and record the relevant results. Pulmonary function testing results will be collected if available. Response will be assessed according to the recommendations of the 2014 NIH response measures publication or any applicable updates. | Up to 6 months |
| Time to next systemic treatment | Any addition of another systemic cGVHD treatment for medical reasons will be considered a failure, whether added because of a new or worsening manifestation of cGVHD, used as a "steroid sparing agent," or substituted due to toxicity. | From the start of the index medication until the addition of another systemic chronic graft versus host disease (cGVHD) treatment with death and treated recurrent malignancy considered competing events, assessed up to 3 years |
| Duration of treatment | Duration of treatment is defined as the time until discontinuation of therapeutic systemic immunosuppression (adrenal replacement and topical/local therapies are allowed) without resumption for at least 3 months. | Up to 3 months |
| Survival | From the start of the index medication to death with patients lost to follow up or alive at the conclusion of the study censored, assessed up to 3 years | |
| Non-relapse mortality | Non-relapse mortality is defined as death in remission, and relapse is considered a competing risk. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic graft-versus-host disease (GVHD) who are starting a new therapy for GVHD
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie J. Lee | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States | ||
| Moffitt Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42385358 | Derived | Hamilton BK, Onstad L, Carpenter PA, Pidala J, Chen G, Cutler C, El Jurdi N, Farhadfar N, Juckett M, Kitko CL, Lee CJ, Lee SJ. Clinical Predictors of Response in Chronic Graft-Versus-Host Disease: Results From the "Predicting the Quality of Response to Specific Treatments (PQRST)" Trial. Am J Hematol. 2026 Jul 1. doi: 10.1002/ajh.70427. Online ahead of print. | |
| 39038701 | Derived | Hamilton BK, Onstad L, Carpenter PA, Pidala J, El Jurdi N, Farhadfar N, Kitko CL, Lee CJ, Mehta R, Chen GL, Cutler C, Lee SJ. Study Protocol: Predicting the Quality of Response to Specific Treatments (PQRST) in Chronic Graft-versus-Host Disease. Contemp Clin Trials. 2024 Oct;145:107637. doi: 10.1016/j.cct.2024.107637. Epub 2024 Jul 20. |
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Blood
| Medical Chart Review | Other | Review of medical chart |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Complete questionnaire |
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| Up to 3 years |
| Patient-reported outcomes | Will be assessed using Lee symptom scale and Patient Reported Outcomes Measurement Information System (PROMIS). The summary score of the Lee Symptom Scale and the PROMIS Global will be calculated according to the instructions of the developers. For analyses assessing change in quality of life, improvement or worsening of the Summary symptom score by 6 points or more or the PROMIS Physical or Mental Functioning scales by 5 points or more compared to baseline will be considered a clinically significant change. | Up to 3 years |
| Tampa |
| Florida |
| 33612 |
| United States |
| Dana-Farber Harvard Cancer Center | Boston | Massachusetts | 02115 | United States |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| Vancouver General Hospital/BC Cancer | Vancouver | British Columbia | V5Z 4E6 | Canada |
| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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