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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00625 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 0S-15-16 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This research trial collects and stores blood, tissue, and bone marrow specimens from patients with cancer or blood disorders, and healthy volunteers to study the immune system in a variety of different types of experiments, as well as associated clinical data as appropriate, focused on understanding mechanisms of immunotherapy.
PRIMARY OBJECTIVES; I. Identify changes in immune system parameters in patients receiving immunotherapies (including immune checkpoint inhibitors, immunostimulatory/immunomodulatory agents, cellular therapies, stem cell transplantation) and compare to changes in patients receiving conventional chemotherapy, targeted-agent therapy, and healthy normal volunteers using multiparameter flow cytometry, time-of-flight mass cytometry, cytokine quantification, functional analysis of immune cell subsets isolated via fluorescence activated cell sorting (FACS), and genetic and proteomic techniques (deoxyribonucleic acid [DNA] sequencing, ribonucleic acid sequence [RNASeq], reverse transcriptase-polymerase chain reaction [RT-PCR], Western blot).
SECONDARY OBJECTIVES:
I. Optimize methods for measuring functional status of circulating immune cells and hematopoietic progenitors (activation, inhibition, cytotoxicity, proliferative capacity).
II. Use genetic and epigenetic techniques to a) study clonal diversity in T cell subsets b) determine the genetic basis for T cell immune reconstitution following stem cell transplantation.
OUTLINE:
Patients and healthy normal volunteers undergo collection of peripheral blood samples for analysis via flow cytometry, RNASeq, immunohistochemistry, cytometry by time of flight (CyTOF) experiments, cell cultures, and functional studies of immune cell subsets obtained by FACS. Patients also undergo collection of bone marrow and leukopheresis/leukoreduction specimens, and single cell suspensions and bulk excised tumor biopsies are obtained from routine testing for analysis via immunohistochemistry or CyTOF.
After completion of study, patients are followed up for up to 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ancillary-correlative (biospecimen collection) | Patients and healthy normal volunteers undergo collection of peripheral blood samples for analysis via flow cytometry, RNASeq, immunohistochemistry, CyTOF experiments, cell cultures, and functional studies of immune cell subsets obtained by FACS. Patients also undergo collection of bone marrow and leukopheresis/leukoreduction specimens, and single cell suspensions and bulk excised tumor biopsies are obtained from routine testing for analysis via immunohistochemistry or CyTOF. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of peripheral blood, bone marrow, and tissue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sample collection for immunology studies from patients with cancer or blood disorders, and healthy volunteers | Tissue, blood, and bone marrow samples collected will be used to identify changes in immune system parameters in patients receiving immunotherapies (including immune checkpoint inhibitors, immunostimulatory/immunomodulatory agents, cellular therapies, stem cell transplantation) and compare to changes in patients receiving conventional chemotherapy, targeted-agent therapy, and healthy normal volunteers using multiparameter flow cytometry, time-of-flight mass cytometry, cytokine quantification, functional analysis of immune cell subsets isolated via fluorescence activated cell sorting (FACS), and genetic and proteomic techniques (deoxyribonucleic acid [DNA] sequencing, ribonucleic acid [RNA]-sequence [Seq], reverse transcriptase-polymerase chain reaction [RT-PCR], Western blot). | Baseline to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients known to have cancer, an immune-mediated hematologic diagnosis, or a healthy normal volunteer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arta Zenunovic | Contact | 323-442 7828 | Arta.zenunovic@med.usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Casey O'Connell, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90033 | United States |
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Blood, bone marrow, tissue
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D019337 | Hematologic Neoplasms |
| D007154 | Immune System Diseases |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
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