Collection of Immunology Specimens From Patients With Cancer or Blood Disorders, and Healthy Volunteers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection, Laboratory Biomarker Analysis, Questionnaire Administration.
- Who it may be relevant to
- Registry conditions: Healthy Subject, Hematologic and Lymphocytic Disorder, Hematopoietic and Lymphoid Cell Neoplasm, Immune System Disorder. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Protocol for Immunology Specimen Collection From Cancer Patients, Patients With Hematologic Diagnoses, and Healthy Normal Controls
Overview
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.
Detailed description
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.
Interventions
- Procedure Biospecimen Collection
Undergo collection of peripheral blood, bone marrow, and tissue - Other Laboratory Biomarker Analysis
Correlative studies - Other Questionnaire Administration
Ancillary studies
Primary outcome measures
- Sample collection for immunology studies from patients with cancer or blood disorders, and healthy volunteers [Time frame: Baseline to 5 years]
Eligibility criteria
Inclusion criteria
- All patients known to have cancer, an immune-mediated hematologic diagnosis, or a healthy normal volunteer
- Definition of immune-mediated hematologic diagnosis: diagnoses for which immune dysfunction and/or immune system directed therapy (eg. aplastic anemia, autoimmune hemolytic anemia, immune thrombocytopenic purpura \[ITP\], etc.) are involved
- Definition of healthy normal volunteer: persons lacking diagnoses of any type of cancer, diabetes, cardiovascular diseases, non-hematologic autoimmune disease (eg. systemic lupus erythematosus \[SLE\], rheumatoid arthritis \[RA\], Crohn's disease) and not taking any immunosuppressive medications
- Patients must have been seen in the Norris Hospital and outpatient clinics, or the Los Angeles County (LAC)-University of Southern California (USC) Medical Center or outpatient clinics; healthy volunteers can be recruited without any physician visit appointments since their labs are strictly for clinical research and not for personal health issues unrelated to the project
Exclusion criteria
- Unable to give informed consent to specimen collection
- Known human immunodeficiency virus (HIV) positive status
- Persons taking any type of immunosuppressive medication are excluded from participating as healthy normal volunteers
- Any patient for whom specimen collection is judged to be unsafe (for example, for patients unable to establish venous access)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- USC / Norris Comprehensive Cancer Center — Los Angeles
Identifiers
NCT: NCT03207854 · 0S-15-16 · NCI-2017-00625 · 0S-15-16 · P30CA014089