Biology Studies of Hematologic Cancers

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT00923442
First received: June 17, 2009
Last updated: May 11, 2016
Last verified: March 2016
  Purpose

This study will collect tumor samples from people with cancers of the blood, bone marrow, or lymph glands for laboratory study of the biology of these conditions. Such studies contribute to a better understanding of cancer biology and to the development of new treatments. Planned studies include:

  • Examination of individual cancer cells and to search for differences compared to other types of cancer and normal cells
  • Examination of the chromosomes and genes in cancer cells and to search for differences compared to other types of cancer and normal cells
  • Development of sensitive methods to detect small amounts of cancer that remain after treatment
  • Search for new cancer proteins that might serve as targets for treatment
  • Investigation of methods to develop cancer vaccines.

Patients from birth to 75 years of age with acute lymphocytic leukemia, acute myelogenous leukemia, myelodysplastic syndrome, chronic myelogenous leukemia, juvenile myelomonocytic leukemia, non-Hodgkin's lymphoma, Hodgkin's disease, and other hematologic malignancies may be eligible for this study.

Blood or bone marrow samples will be collected when sampling is required for the patient's medical care. Cells from some individuals will be grown in test tubes, establishing cell lines or in animals, establishing xenograft models. (A xenograft is transplantation of cells of one species to another species.)


Condition
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome (MDS)
Non-Hodgkins Lymphoma
Acute Myelogenous Leukemia
Hodgkins Lymphoma

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Hematologic Malignancy Biology Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Tissue acquisition for lab investigations [ Time Frame: 1 Month ] [ Designated as safety issue: No ]

Enrollment: 148
Study Start Date: January 2004
Detailed Description:

Background

Laboratory-based investigations have contributed to an improved understanding of pathophysiology and to the development of new therapies for hematologic malignancies.

The aim of this protocol is to facilitate biologic study of leukemias, myelodysplastic syndromes, lymphomas, and other blood disorders.

This is a sample acquisition protocol for targeted study of hematologic malignancies by a collaborative network of NIH investigators from multiple Institutes/Centers.

Objectives

This biology protocol is designed to allow sample acquisition for use in the study of hematologic malignancies. A variety of laboratory investigations designed to support NIH translational trials; to apply new methodologies in the study of cellular, molecular, genetic, and genomic biology; to probe for new therapeutic targets; and to develop new treatment approaches will be performed.

Eligibility

Diagnosis of any hematologic malignancy or pre-malignant blood disorder, including but not restricted to the following: Acute Lymphocytic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myelogenous Leukemia (CML), Juvenile Myelomonocytic Leukemia (JMML, J-CML), Non-Hodgkin s Lymphoma (NHL), Hodgkin s Disease

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.

Patient age: birth to 75 years.

Design

Biologic assays relevant to the investigation of hematologic malignancies will be performed in an exploratory fashion, some studies are developmental, i.e., assay design in support of current or planned CC clinical trials. Others are standard assays that will be applied in attempt to identify new targets or test new therapeutic approaches.

  Eligibility

Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA

Diagnosis of any hematologic malignancy or pre-malignant blood disorder, including but not restricted to the following:

Acute Lymphocytic Leukemia (ALL)

Acute Myelogenous Leukemia (AML)

Myelodysplastic Syndrome (MDS)

Chronic Myelogenous Leukemia (CML)

Juvenile Myelomonocytic Leukemia (JMML, J-CML)

Non-Hodgkin's Lymphoma (NHL)

Hodgkin's Disease

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.

Patient age: birth to 75 years.

Prior therapy: no restrictions

Informed consent or IRB waiver of the requirement for informed consent for specific research studies.

EXCLUSION CRITERIA

  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: NCT00923442

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Terry J Fry, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00923442     History of Changes
Obsolete Identifiers: NCT00900393
Other Study ID Numbers: 040102  04-C-0102 
Study First Received: June 17, 2009
Last Updated: May 11, 2016
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Acute Lymphoblastic Leukemia
Acute Lymphocytic Leukemia
Pediatric Blood Disorders
Hodgkins and non-Hodgkins lymphoma
MDS

Additional relevant MeSH terms:
Lymphoma
Leukemia
Myelodysplastic Syndromes
Preleukemia
Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myeloid
Hodgkin Disease
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on July 26, 2016