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

NCT03207854 | Recruiting DMC

• 3 other identifiers: 0S-15-16NCI-2017-00625P30CA014089
• Study Type: observational
• Target: 625
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of peripheral blood, bone marrow, and tissue

Ancillary-correlative (biospecimen collection)

Laboratory Biomarker Analysis OTHER

Correlative studies

Ancillary-correlative (biospecimen collection)

Questionnaire Administration OTHER

Ancillary studies

Ancillary-correlative (biospecimen collection)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients known to have cancer, an immune-mediated hematologic diagnosis, or a healthy normal volunteer

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, bone marrow, tissue

MeSH Terms

Conditions

Hematologic Diseases; Hematologic Neoplasms; Immune System Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Neoplasms by Site

Study Officials

• Casey O'Connell, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arta Zenunovic

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: July 5, 2017
• Study Start: April 12, 2017
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

US (1)