Tissue Collection for Studies of Lymph Cancer



Status:Recruiting
Conditions:Blood Cancer, Lymphoma, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - 99
Updated:4/5/2019
Start Date:September 21, 2012
Contact:Andrea N Lucas
Email:andrea.lucas@nih.gov
Phone:(240) 760-6252

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Lymphoid Malignancies and Precursors: Tissue Acquisition Protocol

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.

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). 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 will be studied each year. Thus, an
accrual ceiling of 600 consented subjects is planned over 10 years.

- 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.

--Confirmation of 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.

- 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 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 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Phone: 888-624-1937
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Bethesda, MD
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