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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 : April 25, 2024
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Study Description
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Brief Summary:

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.

Condition or disease
Hodgkin Disease Lymphoma, Non-Hodgkin Multiple Myeloma Lymphomatoid Granulomatosis Leukemia-Lymphoma, Adult T-Cell

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 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.

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 is planned over 10 years.

Study Design
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Study Type : Observational
Estimated Enrollment : 650 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lymphoid Malignancies and Precursors: Tissue Acquisition Protocol
Actual Study Start Date : September 21, 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
1
Patients with a known lymphoid malignancy or precursor disease to a lymphoid malignancy
2
Patients without a known lymphoid malignancy or precursor disease to a lymphoid malignancy


Outcome Measures
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Primary Outcome Measures :
  1. 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 appropriate caveats.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary clinical patients seen for a known lymphoid malignancy or precursor disease to a lymphoid malignancy. Patients without a known lymphoid malignancy or precursor disease to a lymphoid malignancy being seen at NIH for another study and who are willing to contribute samples also to this study.
Criteria
  • Lymphoid Malignancies/Diseases:

INCLUSION CRITERIA:

  • Patients with 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 greater than or equal to 18 years of age.
  • ECOG performance 0-2.
  • 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.

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.

  • Hemoglobin greater than or equal to 10 mg/dL and platelet count greater than 75 K/uL.
  • Weight greater than 25 kilograms
  • HIV negative
  • Prothrombin Time - within normal limits
  • Partial Thromboplastin Time - within normal limits
  • Medically indicated central line in place or adequate peripheral venous access

EXCLUSION CRITERIA:

  • Pregnant will not be eligible.
  • Active symptomatic major organ disorder that would increase the risk of biopsy or apheresis, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, 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 mali nancy 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 2.2.2 Exclusion Criteria

EXCLUSION CRITERIA:

  • Pregnant women will not be eligible.
  • Other active malignancy. NOTE: Patients witha 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 discretionof the principal investigator.
Contacts and Locations
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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): NCT01676805


Contacts
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Contact: NCIMO Referral Office (888) 624-1937 ncimo_referrals@mail.nih.gov
Contact: Mark J Roschewski, M.D. (240) 760-6183 mark.roschewski@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY dial 711    ccopr@nih.gov   
Jamaica
University of the West Indies Terminated
Kingston, Jamaica
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mark J Roschewski, M.D. National Cancer Institute (NCI)
More Information
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Additional Information:

Publications:

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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01676805    
Other Study ID Numbers: 120193
12-C-0193
First Posted: August 31, 2012    Key Record Dates
Last Update Posted: April 25, 2024
Last Verified: April 3, 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: All IPD recorded in the medical record will be shared with intramural investigators upon request. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Developing Novel Treatment Approaches
Developing Therapeutic Agents
Analysis of Genetic and Genomic Biology
 New Prognostic and Diagnostic Models
Analysis of Cellular and Molecular Biology
Natural History
Additional relevant MeSH terms:
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Lymphoma
Multiple Myeloma
Hodgkin Disease
Lymphoma, Non-Hodgkin
Lymphomatoid Granulomatosis
Leukemia-Lymphoma, Adult T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
 Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoma, B-Cell
Precancerous Conditions
Leukemia, T-Cell
Leukemia, Lymphoid
Leukemia