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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00898079
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : July 19, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Tracking Information
First Submitted Date May 9, 2009
First Posted Date May 12, 2009
Last Update Posted Date July 19, 2018
Actual Study Start Date October 13, 2003
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 13, 2014)
Repository of malignant, borderline malignant neoplasms, and related biological specimens [ Time Frame: Baseline ]
Original Primary Outcome Measures
 (submitted: May 9, 2009)
Repository of malignant, borderline malignant neoplasms, and related biological specimens
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collecting and Storing Malignant, Borderline Malignant Neoplasms, and Related Samples From Young Patients With Cancer
Official Title A Children's Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors
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 Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Not Provided
Condition
  • Acute Undifferentiated Leukemia
  • Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
  • Childhood Acute Lymphoblastic Leukemia
  • Childhood Acute Myeloid Leukemia
  • Childhood Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Childhood Solid Neoplasm
  • 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
Intervention Other: Cytology Specimen Collection Procedure
Correlative studies
Other Name: Cytologic Sampling
Study Groups/Cohorts Observational
Tumor tissue samples, blood, and bone marrow aspirates are collected and stored for future analysis.
Intervention: Other: Cytology Specimen Collection Procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 17, 2018)
2545
Original Enrollment Not Provided
Actual Study Completion Date June 30, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 30 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Canada,   New Zealand,   Puerto Rico,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00898079
Other Study ID Numbers ABTR01B1
NCI-2009-00324 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000271415
COG-ABTR01B1
ABTR01B1 ( Other Identifier: Childrens Oncology Group )
ABTR01B1 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
UG1CA189958 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Children's Oncology Group
Study Sponsor Children's Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Nilsa Ramirez Children's Oncology Group
PRS Account Children's Oncology Group
Verification Date July 2018