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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorUniversity of Southern California

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

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

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of peripheral blood, bone marrow, and tissue

  • Laboratory Biomarker Analysis

    Other intervention

    Correlative studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

625 Participants
are divided into 1 treatment group
Group A: Ancillary-correlative (biospecimen collection)3 interventions

Trial outcomes

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).

Time frame
Baseline to 5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern California

Lead sponsor

National Cancer Institute (NCI)

Collaborator