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| ID | Type | Description | Link |
|---|---|---|---|
| MT2017-12 | Other Identifier | Masonic Cancer Center, University of Minnesota |
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Accrual goal met
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immune and Microbial Reconstitution |
| ||
| Immune Response Triggered by Severe, Systemic Viral Infection |
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| Immune Response Triggered by Acute Graft-versus-Host Disease |
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| Immune Response Triggered by Chronic Graft-versus-Host Disease |
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| Immune Response Triggered by Relapse |
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| Immune Response Triggered by Cytokine Release Syndrome |
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| Allogeneic Related Donor Samples |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Sample | Diagnostic Test | 60 ml heparinized blood 10 ml serum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immune Function after HCT | Incidence of neutrophil recovery | 7 Years |
| Immune Function after HCT | Incidence of lymphocyte and monocyte subset recovery | 7 Years |
| Immune Function after HCT | Incidence of grade II-IV acute GVHD | 7 Years |
| Immune Function after HCT | Incidence of CMV reactivation | 7 Years |
| Immune Function after Cell Therapy/Immunotherapy | Incidence of neutrophil recovery | 7 Years |
| Immune Function after Cell Therapy/Immunotherapy | Incidence of lymphocyte and monocyte subset recovery | 7 Years |
| Immune Function after Cell Therapy/Immunotherapy | Incidence of cytokine release syndrome (CRS) | 7 Years |
| Correlate Immune Parameters | Correlate the lymphocyte phenotypes, specifically natural killer cell subsets and lymphocyte response to viral antigen. | 7 Years |
| Correlate microbiota changes and their interactions with the host with outcomes of HCT |
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Inclusion Criteria:
Exclusion Criteria:
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All patients receiving care in the University of Minnesota Blood and Marrow Transplant Program
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
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|
| Cellular Therapy Products |
|
| Stool Sample | Diagnostic Test | pea-sized amount |
|
| Urine Sample | Diagnostic Test | 10 ml |
|
| Bronchoalveolar Lavage (BAL) fluid | Diagnostic Test | 10 ml |
|
| Gastrointestinal biopsy x 2-4 | Diagnostic Test | rectosigmoid site preferred |
|
| Skin biopsy | Diagnostic Test | 2-4 mm punch |
|
| Skin, mouth, and/or ocular swab | Diagnostic Test | Involved skin, mouth, and/or ocular swab for microbiota studies |
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| Apheresis Product | Diagnostic Test | Up to 10 ml of apheresis product |
|
| Final cellular product | Diagnostic Test | A second washing from the infusion bag after product and initial bag wash has infused, or up to 10 ml of final cellular product |
|
Correlate microbiota changes and their interactions with the host with outcomes of HCT |
| 7 Years |
| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D009369 | Neoplasms |
| D000080424 | Cytokine Release 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 |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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