Collecting immune system samples from cancer patients, blood disorder patients, and healthy volunteers
Protocol for Immunology Specimen Collection From Cancer Patients, Patients With Hematologic Diagnoses, and Healthy Normal Controls
University of Southern California · NCT03207854
This study is collecting blood and tissue samples from cancer patients, blood disorder patients, and healthy volunteers to see how their immune systems respond to different treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 625 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of Southern California (other) |
| Drugs / interventions | immunotherapy, chemotherapy |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT03207854 on ClinicalTrials.gov |
What this trial studies
This observational study collects and stores blood, tissue, and bone marrow specimens from patients with cancer or blood disorders, as well as healthy volunteers, to investigate the immune system's response to various treatments. The study aims to identify changes in immune parameters in patients receiving immunotherapies compared to those undergoing conventional treatments. Advanced techniques such as flow cytometry, RNA sequencing, and functional analysis of immune cells will be employed to analyze the specimens and associated clinical data. Additionally, the study seeks to optimize methods for measuring immune cell functionality and explore genetic factors influencing immune responses.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with cancer or immune-mediated hematologic disorders, as well as healthy volunteers without any significant medical conditions.
Not a fit: Patients with non-hematologic autoimmune diseases or those currently on immunosuppressive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of immunotherapy mechanisms and improve treatment strategies for cancer and blood disorders.
How similar studies have performed: Other studies have shown success in utilizing similar approaches to understand immune responses, indicating potential for meaningful insights in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Los Angeles, California
- USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States (RECRUITING)
Study contacts
- Principal investigator: Casey O'Connell, MD — University of Southern California
- Study coordinator: Arta Zenunovic
- Email: Arta.zenunovic@med.usc.edu
- Phone: 323-442 7828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy Subject, Hematologic and Lymphocytic Disorder, Hematopoietic and Lymphoid Cell Neoplasm, Immune System Disorder, Malignant Neoplasm