Tissue Collection for Studies of Lymph Cancer
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|ClinicalTrials.gov Identifier: NCT01676805|
Recruitment Status : Recruiting
First Posted : August 31, 2012
Last Update Posted : December 2, 2020
- 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.
- To collect tissue samples to study different types of lymph cancer.
- Individuals at least 18 years of age who have a lymphoid cancer or precancer condition.
- 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.
|Condition or disease|
|Hodgkin Disease Lymphoma, Non-Hodgkin Multiple Myeloma Lymphomatoid Granulomatosis Leukemia-Lymphoma, Adult T-Cell|
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.
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.
Adult patients who meet the following:
- Confirmed pathological diagnosis of lymphoid malignancy or lymphoid precursor, including B-cell and T-cell lymphomas: including but not limited to diffuse large B-cell lymphoma (DLBCL), Hodgkin s lymphoma (HL), multiple myeloma (MM), lymphomatoid granulomatosis (LYG) and adult T-cell leukemia/lymphoma (ATL).
- No known lymphoid malignancy or lymphoid precursor diagnosis and planning a 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.
The purpose of this study is to examine, in an exploratory fashion, a variety of biologic assays relevant to the investigation of lymphoid malignancies.
It is anticipated that up to 60 consented subjects will be studied each year. To account for these anticipated 60 consented subjects in addition to up to potentially 5 screen fails each year, an accrual ceiling of 650 consented subjects is planned over 10 years.
|Study Type :||Observational|
|Estimated Enrollment :||650 participants|
|Official Title:||Lymphoid Malignancies and Precursors: Tissue Acquisition Protocol|
|Actual Study Start Date :||September 21, 2012|
Patients with a known lymphoid malignancy or precursor disease to a lymphoid malignancy
Patients without a known lymphoid malignancy or precursor disease to a lymphoid malignancy
- Sample Acquisition [ 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 appropriatecaveats.
- Obtain normal tissues for the comparative analysis of functional and/or structural genomics [ 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.
- Obtain specimens for genetic analysis, establishment of cell lines, and genomic sequence characterizations [ 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.
- Develop new therapeutic targets using molecular profiling [ 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.
- Assess the use of molecular profiling for pathological diagnosis and response correlation [ 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.
- Establish a comprehensive databank of genomic sequence from patients with Burkitt Lymphoma (BL) [ 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.
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): NCT01676805
|Contact: A. Nicole Lucas||(240) firstname.lastname@example.org|
|Contact: Mark J Roschewski, M.D.||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Mark J Roschewski, M.D.||National Cancer Institute (NCI)|