Tissue Collection for Studies of Lymph Cancer

Official title

Lymphoid Malignancies and Precursors: Tissue Acquisition Protocol

Overview

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.

Detailed description

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:

* Confirmed pathological diagnosis of lymphoid malignancy or lymphoid precursor, including B-cell and T-cell lymphomas: including but not limited to diffuse large Bcell 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.

Design:

* 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 was initially planned over the first 10 years of study. To account for additional consented subjects after the first 10 years of study in addition to samples transferred from other studies, the total accrual ceiling has been increased to 1,292 subjects.

Primary outcome measures

• sample acquisition [Time frame: ongoing]

Secondary outcome measures (5)

• Obtain specimens for genetic analysis, establishment of cell lines, and genomic sequence characterizations [Time frame: baseline and other timepoints TBD by PI/]
• Obtain normal tissues for the comparative analysis of functional and/or structural genomics [Time frame: baseline]
• Establish a comprehensive databank of genomic sequence from patients with Burkitt Lymphoma (BL) [Time frame: baseline through end of study]
• Develop new therapeutic targets using molecular profiling [Time frame: after baseline, through end of study]
• Assess the use of molecular profiling for pathological diagnosis and response correlation [Time frame: baseline through end of study]

Eligibility criteria

• LYMPHOID MALIGNANCIES/DISEASES: The following criteria apply only to patients with a known lymphoid malignancy or precursor

disease, as described:

Inclusion criteria

• Patients with a known lymphoid malignancy or precursor disease to a lymphoid malignancy, including multiple myeloma, 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).
• Confirmation of pathological diagnosis is required from the Laboratory of Pathology, NCI. Tumor tissue that has been previously collected and is available for study or that can be collected with minimal additional risk to the subject during sampling required for routine patient care or required testing on an NIH research protocol will be used for diagnosis.
• Age >= 18 years of age
• Ability of patient or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document NOTE: Patients enrolling with a LAR must be co-enrolled on another study.

Exclusion criteria

• Pregnant individuals will not be eligible.
• Active symptomatic major organ disorder that would increase the risk of biopsy, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, and/or pulmonary dysfunction.
• Active concomitant medical or psychological illnesses that may increase the risk to the subject or inability to obtain informed consent, at the discretion of the principal investigator.

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.

• Age >= 18 years of age
• Must be able and willing to sign informed consent

Exclusion criteria

• Pregnant individuals will not be eligible.
• Other active malignancy. NOTE: Patients with a history of curatively treated basal or squamous cell carcinoma or stage 1 melanoma of the skin as well as any in situ carcinoma are eligible. Patients with a malignancy that has been treated with curative intent and who are without evidence of disease for >=2 years will also be eligible at the discretion of the investigator.
• Active concomitant medical or psychological illnesses that may increase the risk to the subject or inability to obtain informed consent, at the discretion of the principal investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• National Institutes of Health Clinical Center — Bethesda

Jamaica · 1 center

• University of the West Indies — Kingston

Publications

• Rosenwald A, Wright G, Chan WC, Connors JM, Campo E, Fisher RI, Gascoyne RD, Muller-Hermelink HK, Smeland EB, Giltnane JM, Hurt EM, Zhao H, Averett L, Yang L, Wilson WH, Jaffe ES, Simon R, Klausner RD, Powell J, Duffey PL, Longo DL, Greiner TC, Weisenburger DD, Sanger WG, Dave BJ, Lynch JC, Vose J, Armitage JO, Montserrat E, Lopez-Guillermo A, Grogan TM, Miller TP, LeBlanc M, Ott G, Kvaloy S, Dela PMID 12075054
• Lenz G, Staudt LM. Aggressive lymphomas. N Engl J Med. 2010 Apr 15;362(15):1417-29. doi: 10.1056/NEJMra0807082. PMID 20393178
• Rosenwald A, Wright G, Leroy K, Yu X, Gaulard P, Gascoyne RD, Chan WC, Zhao T, Haioun C, Greiner TC, Weisenburger DD, Lynch JC, Vose J, Armitage JO, Smeland EB, Kvaloy S, Holte H, Delabie J, Campo E, Montserrat E, Lopez-Guillermo A, Ott G, Muller-Hermelink HK, Connors JM, Braziel R, Grogan TM, Fisher RI, Miller TP, LeBlanc M, Chiorazzi M, Zhao H, Yang L, Powell J, Wilson WH, Jaffe ES, Simon R, Kla PMID 12975453

Identifiers

NCT: NCT01676805 · 120193 · 12-C-0193

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗