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

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ClinicalTrials.gov Identifier: NCT00898079
Recruitment Status : Active, not recruiting
First Posted : May 12, 2009
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
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

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 Design

Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: A Children's Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors
Study Start Date : March 2003
Estimated Primary Completion Date : January 2100
Estimated Study Completion Date : January 2100


Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Repository of malignant, borderline malignant neoplasms, and related biological specimens [ Time Frame: Baseline ]

Biospecimen Retention:   Samples With DNA
solid tissue (malignant and normal)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898079


  Show 174 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Nilsa Ramirez, MD Children's Oncology Group
More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00898079     History of Changes
Obsolete Identifiers: NCT00228735
Other Study ID Numbers: ABTR01B1
NCI-2009-00324 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ABTR01B1 ( Other Identifier: Children's Oncology Group )
ABTR01B1 ( Other Identifier: Children's Oncology Group )
ABTR01B1 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

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