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

Children's Oncology Group

Status: Completed

Conditions: Childhood Solid Neoplasm; Juvenile Myelomonocytic Leukemia; Childhood Acute Myeloid Leukemia; Mast Cell Leukemia; Secondary Acute Myeloid Leukemia; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Acute Undifferentiated Leukemia; Childhood Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Chronic Lymphocytic Leukemia; Neoplasm of Uncertain Malignant Potential; Childhood Acute Lymphoblastic Leukemia; Hairy Cell Leukemia; T-Cell Large Granular Lymphocyte Leukemia; Prolymphocytic Leukemia

Treatments: Other: Cytology Specimen Collection Procedure

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00898079

ABTR01B1 (Other Identifier)

COG-ABTR01B1

U10CA098543 (U.S. NIH Grant/Contract)

CDR0000271415

UG1CA189958 (U.S. NIH Grant/Contract)

NCI-2009-00324 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,545 patients

Sex: All

Ages: Under 30 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

2,545 participants in 1 patient group

Observational

Description:

Tumor tissue samples, blood, and bone marrow aspirates are collected and stored for future analysis.

Treatment:

Other: Cytology Specimen Collection Procedure