Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
NCT02682667
Blood Protein Disorders, Bronchial Neoplasms
Bethesda, Maryland, United States
View Trial DetailsNCT Number: NCT01676805
Background:
- Lab studies help researchers better understand cancer biology. This information may lead to new methods for diagnosing or treating cancer. To develop these studies, researchers want to collect samples from people with cancer or precancer conditions of the lymph system. These conditions include multiple myeloma, different types of lymphoma, and adult leukemia/lymphoma. The samples collected will include blood, urine, bone marrow, and tumor and skin tissue.
Objectives:
- To collect tissue samples to study different types of lymph cancer.
Eligibility:
- Individuals at least 18 years of age who have a lymphoid cancer or precancer condition.
Design:
* Participants will be screened with a physical exam and medical history. * Different samples will be collected for study. Blood samples will be collected at the initial testing. More blood samples will be collected at different treatment points. Other liquid samples include urine, bone marrow, and any abnormal fluid. Tumor tissue and skin tissue biopsies will also be collected for study. * Treatment will not be provided as part of this study.
Interested in participating?
Request Info18 year and older
All sexes
Observational
University of the West Indies, Kingston, Jamaica
Background:
-An estimated 79,190 people living in the United States will be diagnosed with lymphoma in 2012, including 9,060 cases of HL, 70,130 cases of non-Hodgkin s lymphoma (NHL) and multiple cases of adult T-cell leukemia/lymphoma. Laboratory investigations conducted in the Lymphoid Malignancies Branch, including analysis of cellular, molecular, genetic and genomic biology are attempting to develop new prognostic and diagnostic models, therapeutic agents and novel treatment approaches for lymphoid malignancies and pre malignant conditions.
Objectives:
-This biology protocol is designed to allow sample acquisition for use in the study of lymphoid malignancies and malignancy precursors, including but not limited to B and T cell malignancies, such as diffuse large B-cell lymphoma (DLBCL), Hodgkin s lymphoma (HL), multiple myeloma (MM), lymphomatoid granulomatosis (LYG) and adult T-cell leukemia/lymphoma (ATL) as well as comparison to tissues from patients without lymphoid disease. A variety of laboratory investigations will be conducted on blood, tumor, bone marrow, urine, abnormal fluid and normal tissue, including analysis of cellular, molecular, genetic and genomic biology in the support of NIH translational trials to develop new therapeutic agents and novel treatment approaches as well as new prognostic and diagnostic models.
Eligibility:
-Adult patients who meet one of the following:
Design:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
INCLUSION FOR APHERESIS:
NOTE: This is optional in all patients and will only be requested if the patient is willing, timing allows, and the following criteria are met.
Exclusion criteria
NON-LYMPHOID MALIGNANCIES/DISEASES: The following criteria apply only to patients without a known lymphoid malignancy or precursor disease, as described:
Inclusion criteria
-Patients without a known lymphoid malignancy or lymphoid precursor diagnosis who have a planned surgical procedure during which blood or normal lymph node(s)/tissue (i.e., those not with pre-determined likelihood of abnormality/ malignancy) may be obtained for research studies as part of this protocol
Patient is appropriate to undergo the surgical procedure planned, and consented for the same, as needed. NOTE: This study will not evaluate eligibility of the patient for surgery.
Exclusion criteria
Time frame: ongoing
Standard exploratory and descriptive statistical methods will be used, as appropriate to the specific biologic assay. Any findings will be reported in the context of this exploratory study, with appropriate caveats.
Time frame: baseline and other timepoints TBD by PI/
Genetic analysis, establishment of cell lines, and genomic sequence characterizations will be performed through genetic/genomic studies including analysis of mutations or single nucleotide polymorphisms (SNPs), comparative genomic hybridization, whole genome sequencing, messenger and microRNA sequencing and expression, DNA methylation analysis, DNA copy number analysis, and expression profiling.
Time frame: baseline
Blood, tumor, blood plasma, bone marrow, cheek swabs and abnormal fluids will be obtained from patients without a known lymphoid malignancy or precursor disease to a lymphoid malignancy.
Time frame: baseline through end of study
Contribution of genomic samples to Genomic Databank for Burkitt Lymphoma, created by the Foundation for Burkitt Lymphoma Research.
Time frame: after baseline, through end of study
DNA copy number alterations through Array comparative genomic hybridization, preparation of a Illumina genomic DNA library through methylated DNA immunoprecipitation, and DNA telomere length analysis.
Time frame: baseline through end of study
Determination as to whether the tumor-specific genetic aberrations from the human material can be used as biomarkers that correlate with disease-free survival by using the proprietary method, CAPP-Seq, for analyzing tumor genomic DNA in addition to tumor derived DNA analysis using Real-SeqS.
Contact information is provided by the study sponsor or research team.
Christopher J Melani, M.D.
CONTACT
NCIMO Referral Office
CONTACT
National Cancer Institute (NCI)
Nih
Lymphoid Malignancies and Precursors: Tissue Acquisition Protocol
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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