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

Last updated: July 10, 2025
Sponsor: University of Southern California
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hematological Disorders

Red Blood Cell Disorders

Neoplasms

Treatment

Questionnaire Administration

Biospecimen Collection

Laboratory Biomarker Analysis

Clinical Study ID

NCT03207854
0S-15-16
0S-15-16
NCI-2017-00625
P30CA014089
  • Ages > 19
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients known to have cancer, an immune-mediated hematologic diagnosis, or ahealthy normal volunteer

  • Definition of immune-mediated hematologic diagnosis: diagnoses for which immunedysfunction and/or immune system directed therapy (eg. aplastic anemia, autoimmunehemolytic anemia, immune thrombocytopenic purpura [ITP], etc.) are involved

  • Definition of healthy normal volunteer: persons lacking diagnoses of any type ofcancer, diabetes, cardiovascular diseases, non-hematologic autoimmune disease (eg.systemic lupus erythematosus [SLE], rheumatoid arthritis [RA], Crohn's disease) andnot taking any immunosuppressive medications

  • Patients must have been seen in the Norris Hospital and outpatient clinics, or theLos Angeles County (LAC)-University of Southern California (USC) Medical Center oroutpatient clinics; healthy volunteers can be recruited without any physician visitappointments since their labs are strictly for clinical research and not forpersonal health issues unrelated to the project

Exclusion

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 fromparticipating as healthy normal volunteers

  • Any patient for whom specimen collection is judged to be unsafe (for example, forpatients unable to establish venous access)

Study Design

Total Participants: 500
Treatment Group(s): 3
Primary Treatment: Questionnaire Administration
Phase:
Study Start date:
April 12, 2017
Estimated Completion Date:
April 12, 2027

Study 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.

Connect with a study center

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Active - Recruiting

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