Clinical trial NCT00923442: Biology Studies of Hematologic Cancers
Official title: Hematologic Malignancy Biology Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome (MDS)
Non-Hodgkins Lymphoma
Acute Myelogenous Leukemia
Hodgkins Lymphoma
Keywords: Acute Lymphoblastic Leukemia
Acute Lymphocytic Leukemia
Pediatric Blood Disorders
Hodgkins and non-Hodgkins lymphoma
MDS
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2009-06-18
Enrollment: 550
Sex: ALL
Minimum age (years): 1
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tumor tissue of patients whose ages range from birth to 75 years old diagnosed with any hematologic malignancy or pre-malignant blood disorder

Brief 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.)

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, 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.

.

Eligibility criteria: * 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.

Age: \>= 1 and \<= 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

Primary outcomes:
measure: Tissue acquisition for lab investigations
timeFrame: 1 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Nirali N Shah, M.D.
role: PRINCIPAL_INVESTIGATOR
References: