Biology Studies of Hematologic Cancers

April 24, 2024 updated by: National Cancer Institute (NCI)

Hematologic Malignancy Biology Study

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.)

Study Overview

Status

Enrolling by invitation

Conditions

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.

.

Study Type

Observational

Enrollment (Estimated)

550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
patients (from >/= 1 to 75 years old) diagnosed with any hematologic malignancy or pre-malignant condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue acquisition for lab investigations
Time Frame: 1 Month
The examination of biologic assays relevant to the investigation of hematologic malignancies
1 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Nirali N Shah, M.D., National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2004

Study Registration Dates

First Submitted

June 17, 2009

First Submitted That Met QC Criteria

June 17, 2009

First Posted (Estimated)

June 18, 2009

Study Record Updates

Last Update Posted (Estimated)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

March 21, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 040102
  • 04-C-0102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

.All IPD recorded in the medical record will be shared with intramural investigators upon request.

IPD Sharing Time Frame

Clinical data available during the study and indefinitely.

IPD Sharing Access Criteria

Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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