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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00898079
Registration number
NCT00898079
Ethics application status
Date submitted
9/05/2009
Date registered
12/05/2009
Date last updated
19/07/2018
Titles & IDs
Public title
Collecting and Storing Malignant, Borderline Malignant Neoplasms, and Related Samples From Young Patients With Cancer
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Scientific title
A Children's Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors
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Secondary ID [1]
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NCI-2009-00324
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Secondary ID [2]
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ABTR01B1
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Undifferentiated Leukemia
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Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
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Childhood Acute Lymphoblastic Leukemia
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Childhood Acute Myeloid Leukemia
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Childhood Chronic Myelogenous Leukemia, BCR-ABL1 Positive
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Childhood Solid Neoplasm
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Chronic Lymphocytic Leukemia
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Hairy Cell Leukemia
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Juvenile Myelomonocytic Leukemia
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Mast Cell Leukemia
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Neoplasm of Uncertain Malignant Potential
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Prolymphocytic Leukemia
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Secondary Acute Myeloid Leukemia
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T-Cell Large Granular Lymphocyte Leukemia
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Cytology Specimen Collection Procedure
Observational - Tumor tissue samples, blood, and bone marrow aspirates are collected and stored for future analysis.
Other interventions: Cytology Specimen Collection Procedure
Correlative studies
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Intervention code [1]
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Other interventions
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Control group
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Outcomes
Primary outcome [1]
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Repository of malignant, borderline malignant neoplasms, and related biological specimens
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Assessment method [1]
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Timepoint [1]
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Baseline
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Eligibility
Key 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
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Minimum age
No limit
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Maximum age
30
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/10/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/06/2018
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Sample size
Target
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Accrual to date
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Final
2545
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Recruitment in Australia
Recruitment state(s)
SA,WA
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Recruitment hospital [1]
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Women's and Children's Hospital-Adelaide - North Adelaide
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Recruitment hospital [2]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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5006 - North Adelaide
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Recruitment postcode(s) [2]
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6008 - Perth
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Recruitment outside Australia
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Alabama
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Colorado
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Connecticut
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Delaware
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District of Columbia
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San Juan
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Geneva
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Address [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00898079
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Nilsa Ramirez
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Address
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Children's Oncology Group
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00898079
Download to PDF