A Children's Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors

Children's Oncology Group192 sites in 1 country2,545 target enrollmentOctober 13, 2003

ConditionsAcute Undifferentiated Leukemia Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Childhood Acute Lymphoblastic Leukemia Childhood Acute Myeloid Leukemia Childhood Chronic Myelogenous Leukemia, BCR-ABL1 Positive Childhood Solid Neoplasm 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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Undifferentiated Leukemia
Sponsor: Children's Oncology Group
Enrollment: 2545
Locations: 192
Primary Endpoint: Repository of malignant, borderline malignant neoplasms, and related biological specimens
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 13, 2003

End Date

June 30, 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Children's Oncology Group

Responsible Party

Sponsor

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)