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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT00923442
Other study ID # 040102
Secondary ID 04-C-0102
Status Enrolling by invitation
Phase
First received
Last updated
Start date February 24, 2004

Study information

Verified date June 10, 2024
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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 >= 1 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.)


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, pre-malignant conditions, 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. Objective: 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, and molecular 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 conditions, 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: >= 1 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. .


Other known NCT identifiers
  • NCT00900393

Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 550
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 1 Year to 75 Years
Eligibility - INCLUSION CRITERIA Confirmed pathological 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: >= 1 to 75 years. Prior therapy: no restrictions Subject, parent/guardian, legally authorized representative (LAR), or durable power of attorney must be able to give informed consent and sign the informed consent document. EXCLUSION CRITERIA None

Study Design


Locations

Country Name City State
United States National Institutes of Health Clinical Center Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tissue acquisition for lab investigations The examination of biologic assays relevant to the investigation of hematologic malignancies 1 Month
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