Hematopoietic and Lymphoid Cell Neoplasm
Conditions
Brief summary
This trial observes and collects samples from patients before and after stem cell transplantation to learn more about how and why a complication called chronic graft-versus-host disease (GVHD) develops after stem cell transplantation. Performing close observation and various types of testing may enable doctors to notice symptoms or problems sooner than they would normally have been noticed and predict which patients will develop chronic GVHD.
Detailed description
OUTLINE: Patients undergo collection of tears, saliva, buccal mucosa, and fecal samples before stem cell transplant, at 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients also undergo collection of blood samples before stem cell transplant, at 1-2, 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients may undergo skin and mouth biopsy over 15-30 minutes before stem cell transplant, at 2-3 and 12 months after stem cell transplant, and at cGVHD onset. Patients undergo digital pictures of the eyes, mouth and skin, and optical coherence tomographybefore stem cell transplant, at 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients without standard of care formal pulmonary function test undergo portable spirometry at 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients also complete surveys and have their medical records reviewed. After completion of study, patients are followed up periodically.
Interventions
PROCEDUREBiospecimen Collection
Undergo collection of blood, tears, saliva, buccal mucosa, feces, and tissue samples
PROCEDUREOptical Coherence Tomography
Undergo optical coherence tomography
PROCEDURESpirometry
Undergo portable spirometry
OTHERSurvey Administration
Complete survey
OTHERDigital Photography
Undergo digital photography
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERMedical Chart Review
Review of medical charts
Sponsors
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Fred Hutchinson Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults age 18 or older * Scheduled for allogeneic HCT from any donor for any indication, with a risk of cGVHD of \> 25% (see below in
Exclusion criteria
for treatment plans with a cGVHD risk \< 25%) * Ability and willingness to comply with the intensive assessment schedule including evaluation every other month at a participating site * Ability to communicate in English or Spanish, to allow completion of patient surveys and clear communication with the study team
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Levels of cytokines | Up to 3 years | Will compare the pg/ml levels and trajectories of proteins (IL-1b; IL-4; IL-5; IL-6; IL-8; IL-10; IL-13; IL-17a (pg/mL); TNF; G-CSF; IFNgamma; MCP-1; IL-12p40; GM-CSF; IL-2) between patients who do and do not develop chronic graft versus host disease (cGVHD). Blood will be analyzed separately from saliva and conjunctival washings. |
| Onset of cGVHD | Up to 3 years | Onset of cGVHD will be treated as a time-to-event endpoint, using Cox regression with monthly levels or slopes of the markers entered as time dependent covariates. |
| Percentage of cellular populations | Up to 3 years | Will compare the levels, proportions and trajectories of different cellular populations between those with and without cGVHD, and with different cGVHD organ involvement and symptoms. The following cell subtypes are of highest interest: Th17, FOXP3+ T regulatory cells, FOXP3- T regulatory type 1 (TR1) cells, T follicular helper cells, activated B cells, B regulatory cells, and monocytes but the list may evolve before actual testing. |
| Number of patients with tissue alterations in skin, mouth and eyes | Up to 3 years | Tissue alterations will be classified into Abnormal and Normal, and measured by biopsy and/or advanced bioimaging techniques. Histologic findings, ribonucleic acid (RNA) expression profiles, optical coherence tomography (OCT) findings and digital image interpretations will be compared between patients who do and do not develop cGVHD or who have different cGVHD clinical phenotypes and symptoms. |
Countries
United States
Outcome results
None listed