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Collecting and Storing Malignant, Borderline Malignant Neoplasms, and Related Samples From Young Patients With Cancer

Descriptive Information
Brief Title † Collecting and Storing Malignant, Borderline Malignant Neoplasms, and Related Samples From Young Patients With Cancer
Official Title † A Children's Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors
Brief Summary This study is collecting and storing malignant, borderline malignant neoplasms, and related biological samples from young patients with cancer. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help the study of cancer in the future.
Detailed Description OBJECTIVES: I. Collect malignant, borderline malignant neoplasms, and related biological specimens from Children's Oncology Group institutions for cases in which there is no disease-specific biologic protocol. II. Provide a repository for long-term storage of malignant, borderline malignant neoplasms, and related biological specimens from these patients. III. Make specimens available to qualified researchers to understand the biology of cancer in these patients. OUTLINE: Tumor tissue samples, blood, and bone marrow aspirates are collected and stored for future analysis.
Study Phase N/A
Study Type † Observational
Study Design † Time Perspective: Retrospective
Primary Outcome Measure † Repository of malignant, borderline malignant neoplasms, and related biological specimens
Secondary Outcome Measure †
Condition † Acute Undifferentiated Leukemia Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Childhood Acute Lymphoblastic Leukemia Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies Childhood Chronic Myelogenous Leukemia Chronic Lymphocytic Leukemia Hairy Cell Leukemia Juvenile Myelomonocytic Leukemia Mast Cell Leukemia Neoplasm of Uncertain Malignant Potential Prolymphocytic Leukemia Secondary Acute Myeloid Leukemia T-cell Large Granular Lymphocyte Leukemia Unspecified Childhood Solid Tumor, Protocol Specific
Intervention † Othercytology specimen collection procedure
Study Arms / Comparison Groups Observational Tumor tissue samples, blood, and bone marrow aspirates are collected and stored for future analysis.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Other
Estimated Enrollment † 3000
Start Date † March 2003
Completion Date
Primary Completion Date January 2100
Eligibility Criteria † Inclusion Criteria: - Meets any of the following criteria: - Diagnosed with primary neoplasm - Developed a second malignant neoplasm - Any diagnoses having an ICD-O Morphology Code ending in 1, 2, or 3 as listed in the International Classification of Disease for Oncology, Third Edition - Must have biological specimens including solid tumors and leukemias available - Solid tumors meeting the following criteria: - Snap frozen primary tumor OR OCT embedded primary tumor OR formalin fixed (block or tissue in formalin) primary tumor AND at least 10 unstained paraffin slides for NIH Mandated QC (tumors that have undergone central pathology review are allowed) - Slides for pathology review (instead of slides for QC) are required for patients with rare tumors - Pleural fluid or cytologic specimens meeting the following criteria: - At least 1 mL of fluid and at least 2 unstained cytospin slides (or 2 unstained smears) - Slides for pathology review (instead of slides for QC) are required for patients with rare tumors - ALL/AML - 3-6 mL of bone marrow aspirate and 10 mL of whole blood - Not eligible for disease-specific biology or banking protocol
Gender Both
Ages N/A - 30 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Australia
Administrative Information
NCT ID † NCT00898079
Organization ID ABTR01B1
Secondary IDs †† NCI-2009-00324, COG-ABTR01B1, ABTR01B1, ABTR01B1, U10CA098543
Responsible Party Sponsor
Study Sponsor † Children's Oncology Group
Collaborators †† National Cancer Institute (NCI)
Investigators † Principal Investigator: Nilsa Ramirez, MD, Children's Oncology Group
Information Provided By
Verification Date November 2016
First Received Date † May 9, 2009
Last Updated Date November 23, 2016
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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