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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
A Children's Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors
Secondary ID [1] 0 0
NCI-2009-00324
Secondary ID [2] 0 0
ABTR01B1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Undifferentiated Leukemia 0 0
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative 0 0
Childhood Acute Lymphoblastic Leukemia 0 0
Childhood Acute Myeloid Leukemia 0 0
Childhood Chronic Myelogenous Leukemia, BCR-ABL1 Positive 0 0
Childhood Solid Neoplasm 0 0
Chronic Lymphocytic Leukemia 0 0
Hairy Cell Leukemia 0 0
Juvenile Myelomonocytic Leukemia 0 0
Mast Cell Leukemia 0 0
Neoplasm of Uncertain Malignant Potential 0 0
Prolymphocytic Leukemia 0 0
Secondary Acute Myeloid Leukemia 0 0
T-Cell Large Granular Lymphocyte Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Repository of malignant, borderline malignant neoplasms, and related biological specimens
Timepoint [1] 0 0
Baseline

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
Minimum age
No limit
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/10/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2018
Sample size
Target
Accrual to date
Final
2545
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Women's and Children's Hospital-Adelaide - North Adelaide
Recruitment hospital [2] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
5006 - North Adelaide
Recruitment postcode(s) [2] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
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Florida
Country [10] 0 0
United States of America
State/province [10] 0 0
Georgia
Country [11] 0 0
United States of America
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Hawaii
Country [12] 0 0
United States of America
State/province [12] 0 0
Idaho
Country [13] 0 0
United States of America
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Illinois
Country [14] 0 0
United States of America
State/province [14] 0 0
Indiana
Country [15] 0 0
United States of America
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Iowa
Country [16] 0 0
United States of America
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Kansas
Country [17] 0 0
United States of America
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Kentucky
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United States of America
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Louisiana
Country [19] 0 0
United States of America
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Maine
Country [20] 0 0
United States of America
State/province [20] 0 0
Maryland
Country [21] 0 0
United States of America
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Massachusetts
Country [22] 0 0
United States of America
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Michigan
Country [23] 0 0
United States of America
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Minnesota
Country [24] 0 0
United States of America
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Mississippi
Country [25] 0 0
United States of America
State/province [25] 0 0
Missouri
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United States of America
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Nebraska
Country [27] 0 0
United States of America
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Nevada
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United States of America
State/province [28] 0 0
New Jersey
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United States of America
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New Mexico
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United States of America
State/province [30] 0 0
New York
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United States of America
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North Carolina
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United States of America
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North Dakota
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United States of America
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Ohio
Country [34] 0 0
United States of America
State/province [34] 0 0
Oklahoma
Country [35] 0 0
United States of America
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Oregon
Country [36] 0 0
United States of America
State/province [36] 0 0
Pennsylvania
Country [37] 0 0
United States of America
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South Carolina
Country [38] 0 0
United States of America
State/province [38] 0 0
South Dakota
Country [39] 0 0
United States of America
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Tennessee
Country [40] 0 0
United States of America
State/province [40] 0 0
Texas
Country [41] 0 0
United States of America
State/province [41] 0 0
Utah
Country [42] 0 0
United States of America
State/province [42] 0 0
Vermont
Country [43] 0 0
United States of America
State/province [43] 0 0
Virginia
Country [44] 0 0
United States of America
State/province [44] 0 0
Washington
Country [45] 0 0
United States of America
State/province [45] 0 0
West Virginia
Country [46] 0 0
United States of America
State/province [46] 0 0
Wisconsin
Country [47] 0 0
Canada
State/province [47] 0 0
Alberta
Country [48] 0 0
Canada
State/province [48] 0 0
British Columbia
Country [49] 0 0
Canada
State/province [49] 0 0
Manitoba
Country [50] 0 0
Canada
State/province [50] 0 0
Nova Scotia
Country [51] 0 0
Canada
State/province [51] 0 0
Ontario
Country [52] 0 0
Canada
State/province [52] 0 0
Quebec
Country [53] 0 0
Canada
State/province [53] 0 0
Saskatchewan
Country [54] 0 0
New Zealand
State/province [54] 0 0
Auckland
Country [55] 0 0
Puerto Rico
State/province [55] 0 0
San Juan
Country [56] 0 0
Switzerland
State/province [56] 0 0
Geneva

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00898079
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nilsa Ramirez
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00898079