Recruiting

Immunotherapy Research

Sponsor:

University of Southern California

Code:

NCT03207854

Conditions

Healthy Subject

Hematologic and Lymphocytic Disorder

Hematopoietic and Lymphoid Cell Neoplasm

Immune System Disorder

Malignant Neoplasm

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

Interventions

Biospecimen Collection

Laboratory Biomarker Analysis

Questionnaire Administration

Study Details

Brief 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.

Conditions

Healthy Subject

Hematologic and Lymphocytic Disorder

Hematopoietic and Lymphoid Cell Neoplasm

Immune System Disorder

Malignant Neoplasm

Study ID

NCT03207854

Start date

Apr 12, 2017

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

625 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Biospecimen Collection

Undergo collection of peripheral blood, bone marrow, and tissue

Laboratory Biomarker Analysis

Correlative studies

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Sample collection for immunology studies from patients with cancer or blood disorders, and healthy volunteers [ Time Frame: Baseline to 5 years ]

Central Contacts and Locations

Central contacts

Arta Zenunovic

323-442 7828Arta.zenunovic@med.usc.edu

Locations

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Arta Zenunovic

323-442-5771Arta.zenunovic@med.usc.edu

Principal Investigator:

Casey O'Connell, MS

More Information

Sponsor

University of Southern California

Last update posted

Apr 2, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-04-02.