Tissue Collection for Studies of Lymph Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01676805
First received: August 29, 2012
Last updated: May 16, 2014
Last verified: April 2014
  Purpose

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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Lymphoid Malignancies and Precursors: Tissue Acquisition Protocol

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Sample Acquisition [ Time Frame: Open ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparative analysis of normal and tumor tissue [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Development of new therapeutic targets using molecular profiling. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: August 2012
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 Metabolism 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 premalignant 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). 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 with 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).

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, 50 at the NCI site, 10 at the UWI site, will be studied each year. Thus, an accrual ceiling of 600 consented subjects is planned over 10 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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).
  • Confirmed pathological diagnosis.

    • At NCI site, the 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.
    • At the UWI site, diagnosis is as required per contract HH5N261200800011C.
  • Greater than or equal to 18 years of age.
  • ECOG performance 0-2.
  • Must be willing and able to provide informed consent.

INCLUSION FOR APHERESIS:

  • Hemoglobin greater than or equal to 10 milligrams per deciliter and platelet count greater than 75,000 per cubic millimeter.
  • 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 or breast feeding women will not be eligible for any aspect of this protocol except phlebotomy.
  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676805

Contacts
Contact: Margaret Shovlin, R.N. (301) 594-6597 mshovlin@mail.nih.gov
Contact: Wyndham H Wilson, M.D. (301) 435-2415 wilsonw@mail.nih.gov

Locations
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      
Jamaica
University of the West Indies Recruiting
Kingston, Jamaica
Sponsors and Collaborators
Investigators
Principal Investigator: Wyndham H Wilson, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01676805     History of Changes
Other Study ID Numbers: 120193, 12-C-0193
Study First Received: August 29, 2012
Last Updated: May 16, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Developing Novel Treatment Approaches
Developing Therapeutic Agents
Analysis of Genetic and Genomic Biology
New Prognostic and Diagnostic Models
Analysis of Cellular and Molecular Biology

Additional relevant MeSH terms:
Hodgkin Disease
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphatic Diseases
Precancerous Conditions
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma
Lymphomatoid Granulomatosis
Lymphoma, Non-Hodgkin
Leukemia-Lymphoma, Adult T-Cell
Neoplasms by Histologic Type
Neoplasms
Paraproteinemias
Lymphoma, B-Cell
Leukemia, T-Cell
Leukemia, Lymphoid
Leukemia

ClinicalTrials.gov processed this record on October 16, 2014