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

This study is currently recruiting participants.
Verified February 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: February 13, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Children's Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Repository of malignant, borderline malignant neoplasms, and related biological specimens [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

solid tissue (malignant and normal)


Estimated Enrollment: 3000
Study Start Date: March 2003
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational
Tumor tissue samples, blood, and bone marrow aspirates are collected and stored for future analysis.
Other: cytology specimen collection procedure
Correlative studies
Other Name: cytologic sampling

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.

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898079

  Show 179 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Nilsa Ramirez, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00898079     History of Changes
Obsolete Identifiers: NCT00228735
Other Study ID Numbers: ABTR01B1, NCI-2009-00324, CDR0000271415, COG-ABTR01B1, ABTR01B1, ABTR01B1, U10CA098543
Study First Received: May 9, 2009
Last Updated: February 13, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Hairy Cell
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Mast-Cell
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Prolymphocytic
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Leukemia, Large Granular Lymphocytic
Neoplasms by Histologic Type
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Mastocytosis, Systemic
Mastocytosis
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Myelodysplastic-Myeloproliferative Diseases

ClinicalTrials.gov processed this record on April 17, 2014