Acute-graft-versus-host Disease, Allogenic Related Donors, Cell Therapy/Immunotherapy Patients, Chronic Graft-versus-host-disease, Cytokine Release Syndrome, Immune and Microbial Reconstitution, Recurrent Malignancy, Systemic Viral Infection
Conditions
Brief summary
This protocol serves as a mechanism to collect, store, and distribute bodily fluid and tissue samples obtained from Hematopoietic Cell Transplant (HCT) or novel immunotherapy patients and their donors at the Masonic Cancer Center in order to conduct correlative studies of the immune system, microbiota, and their interactions. Fluid (including but not limited to, blood, urine, saliva, cerebrospinal fluid, bronchoalveolar lavage fluid) sample log-in, processing, relabeling, and storage is performed by the Masonic Cancer Center (MCC) Translational Therapy Lab (TTL).
Interventions
DIAGNOSTIC_TESTStool Sample
pea-sized amount
DIAGNOSTIC_TESTBlood Sample
60 ml heparinized blood 10 ml serum
DIAGNOSTIC_TESTUrine Sample
10 ml
DIAGNOSTIC_TESTBronchoalveolar Lavage (BAL) fluid
10 ml
DIAGNOSTIC_TESTGastrointestinal biopsy x 2-4
rectosigmoid site preferred
DIAGNOSTIC_TESTSkin biopsy
2-4 mm punch
DIAGNOSTIC_TESTSkin, mouth, and/or ocular swab
Involved skin, mouth, and/or ocular swab for microbiota studies
DIAGNOSTIC_TESTApheresis Product
Up to 10 ml of apheresis product
DIAGNOSTIC_TESTFinal cellular product
A second washing from the infusion bag after product and initial bag wash has infused, or up to 10 ml of final cellular product
Sponsors
Masonic Cancer Center, University of Minnesota
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients planning to undergo HCT or other cellular therapy/immunotherapy * Allogeneic related donors * Aged 0-80 * Willing and able to sign voluntary written consent
Exclusion criteria
* Patients whose medical record indicates that they have opted out of research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune Function after HCT | 7 Years | Incidence of neutrophil recovery |
| Immune Function after Cell Therapy/Immunotherapy | 7 Years | Incidence of neutrophil recovery |
| Correlate Immune Parameters | 7 Years | Correlate the lymphocyte phenotypes, specifically natural killer cell subsets and lymphocyte response to viral antigen. |
| Correlate microbiota changes and their interactions with the host with outcomes of HCT | 7 Years | Correlate microbiota changes and their interactions with the host with outcomes of HCT |
Countries
United States
Outcome results
None listed