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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00898079
First received: May 9, 2009
Last updated: August 21, 2014
Last verified: August 2014

May 9, 2009
August 21, 2014
March 2003
January 2100   (final data collection date for primary outcome measure)
Repository of malignant, borderline malignant neoplasms, and related biological specimens [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Repository of malignant, borderline malignant neoplasms, and related biological specimens [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00898079 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Collecting and Storing Malignant, Borderline Malignant Neoplasms, and Related Samples From Young Patients With Cancer
A Children's Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors

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.

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.

Observational
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

solid tissue (malignant and normal)

Non-Probability Sample

Any patient diagnosed with primary neoplasm, who 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.

  • 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
Other: cytology specimen collection procedure
Correlative studies
Other Name: cytologic sampling
Observational
Tumor tissue samples, blood, and bone marrow aspirates are collected and stored for future analysis.
Intervention: Other: cytology specimen collection procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
Not Provided
January 2100   (final data collection date for primary outcome measure)

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
Both
up to 30 Years
No
United States,   Australia,   Canada,   New Zealand,   Puerto Rico,   Switzerland
 
NCT00898079
ABTR01B1, NCI-2009-00324, CDR0000271415, COG-ABTR01B1, ABTR01B1, ABTR01B1, U10CA098543
No
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Nilsa Ramirez, MD Children's Oncology Group
Children's Oncology Group
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP