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Trial record 67 of 961 for:    bone tumors AND NOT metastatic | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03207854
Recruitment Status : Recruiting
First Posted : July 5, 2017
Last Update Posted : September 19, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

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.

Condition or disease Intervention/treatment
Healthy Subject Hematologic and Lymphocytic Disorder Hematopoietic and Lymphoid Cell Neoplasm Immune System Disorder Malignant Neoplasm Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis Other: Questionnaire Administration

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Protocol for Immunology Specimen Collection From Cancer Patients, Patients With Hematologic Diagnoses, and Healthy Normal Controls
Actual Study Start Date : April 12, 2017
Estimated Primary Completion Date : April 12, 2022
Estimated Study Completion Date : April 12, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Disorders

Group/Cohort Intervention/treatment
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
Undergo collection of peripheral blood, bone marrow, and tissue

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Sample collection for immunology studies from patients with cancer or blood disorders, and healthy volunteers [ Time Frame: Baseline to 5 years ]
    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).


Biospecimen Retention:   Samples With DNA
Blood, bone marrow, tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients known to have cancer, an immune‐mediated hematologic diagnosis, or a healthy normal volunteer
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207854


Contacts
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Contact: Arta Zenunovic 323-442 7828 Arta.zenunovic@med.usc.edu

Locations
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United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Arta Zenunovic    323-442-5771    Arta.zenunovic@med.usc.edu   
Principal Investigator: Akil A. Merchant, MD         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Akil Merchant, MD University of Southern California

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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03207854     History of Changes
Other Study ID Numbers: 0S-15-16
NCI-2017-00625 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
0S-15-16 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Neoplasms
Hematologic Neoplasms
Immune System Diseases
Hematologic Diseases
Pathologic Processes
Neoplasms by Site