Collection of Immunology Specimens From Patients With Cancer or Blood Disorders, and Healthy Volunteers

  • STATUS
    Recruiting
  • End date
    Apr 12, 2023
  • participants needed
    500
  • sponsor
    University of Southern California
Updated on 24 February 2022
diabetes
cardiovascular disease
cancer
immunosuppressant
anemia
immunosuppressive
immunosuppressive agents
blood disorder
bone marrow procedure
primary cancer
autoimmune disease
hematologic disorders
systemic lupus erythematosus
Accepts healthy volunteers

Summary

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.

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.

Details
Condition Healthy Subject, Hematologic and Lymphocytic Disorder, Hematopoietic and Lymphoid Cell Neoplasm, Immune System Disorder, Malignant Neoplasm
Treatment laboratory biomarker analysis, questionnaire administration, biospecimen collection
Clinical Study IdentifierNCT03207854
SponsorUniversity of Southern California
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

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)
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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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