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

Malignant Neoplasm Clinical Trial

Official title:

Protocol for Immunology Specimen Collection From Cancer Patients, Patients With Hematologic Diagnoses, and Healthy Normal Controls

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03207854
• Other study ID #: 0S-15-16
• Secondary ID: NCI-2017-006250S
• Status: Recruiting
• Start date: April 12, 2017
• Est. completion date: April 12, 2025

Study information

• Verified date: August 2023
• Source: University of Southern California
• Contact: Arta Zenunovic
• Phone: 323-442 7828
• Email: Arta.zenunovic[@]med.usc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 12, 2025
• Est. primary completion date: April 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Subject
• Hematologic and Lymphocytic Disorder
• Hematologic Diseases
• Hematopoietic and Lymphoid Cell Neoplasm
• Immune System Diseases
• Immune System Disorder
• Malignant Neoplasm
• Neoplasms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of peripheral blood, bone marrow, and tissue

Other:
• Laboratory Biomarker Analysis
Correlative studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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