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

Completed

• Conditions: Hairy Cell Leukemia; Secondary Acute Myeloid Leukemia; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Neoplasm of Uncertain Malignant Potential; Chronic Lymphocytic Leukemia; Acute Undifferentiated Leukemia; Childhood Acute Lymphoblastic Leukemia; Childhood Acute Myeloid Leukemia; Childhood Solid Neoplasm; Juvenile Myelomonocytic Leukemia

• Registration Number: NCT00898079
• Lead Sponsor: Children's Oncology Group

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 Timeline

• Study Start: 2003-10-13
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2545

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Repository of malignant, borderline malignant neoplasms, and related biological specimens	Baseline

Trial Locations

Locations (192)

Children's Hospital of Alabama; 🇺🇸 Birmingham, Alabama, United States

University of Alabama at Birmingham Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Phoenix Childrens Hospital; 🇺🇸 Phoenix, Arizona, United States

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Kaiser Permanente Downey Medical Center; 🇺🇸 Downey, California, United States

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

Miller Children's and Women's Hospital Long Beach; 🇺🇸 Long Beach, California, United States

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

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