Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00899275




Registration number
NCT00899275
Ethics application status
Date submitted
9/05/2009
Date registered
12/05/2009
Date last updated
3/10/2023

Titles & IDs
Public title
Collecting and Storing Samples of Blood and Tumor Tissue From Patients With Osteosarcoma
Scientific title
A Children?s Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens
Secondary ID [1] 0 0
NCI-2009-00410
Secondary ID [2] 0 0
AOST06B1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteosarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Children's - Other

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

Ancillary-correlative - After the initial submission of blood samples, patients may undergo open or closed biopsy in order to obtain fresh and frozen tissue samples as well as paraffin embedded material. Patients who are enrolled at the time of initial diagnosis but then have a definitive surgery or develop recurrent disease may submit additional samples (paraffin block, frozen and fresh tumor tissue, or slides together with blood samples). Autopsy tumor samples may also be submitted.


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
Collection of biological specimens from patients with osteosarcoma
Timepoint [1] 0 0
Baseline

Eligibility
Key inclusion criteria
* All osteosarcoma patients seen at COG institutions are eligible, including the following:

* Newly diagnosed patients
* Patients with recurrent disease who were not enrolled at the time of diagnosis
* The following specimens from the initial biopsy (and/or definitive surgery if an up-front resection is performed) are required:

* Paraffin embedded block OR 30 unstained slides
* Pretreatment blood consisting of 5 mL serum, 10 mL plasma, and 10 mL heparinized whole blood
* Fresh and frozen tumor specimens
* Patients are not required to enter a therapeutic study to enroll on this study
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2023
Sample size
Target
Accrual to date
Final
957
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [2] 0 0
Royal Children's Hospital-Brisbane - Herston
Recruitment hospital [3] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [4] 0 0
Women's and Children's Hospital-Adelaide - North Adelaide
Recruitment hospital [5] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
5006 - North Adelaide
Recruitment postcode(s) [4] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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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
State/province [9] 0 0
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
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Idaho
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United States of America
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Illinois
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Indiana
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Iowa
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Kansas
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United States of America
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Kentucky
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Louisiana
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Maine
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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Nevada
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New Hampshire
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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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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
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United States of America
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Oklahoma
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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South Dakota
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United States of America
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Tennessee
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United States of America
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Texas
Country [42] 0 0
United States of America
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Utah
Country [43] 0 0
United States of America
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Vermont
Country [44] 0 0
United States of America
State/province [44] 0 0
Virginia
Country [45] 0 0
United States of America
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Washington
Country [46] 0 0
United States of America
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West Virginia
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United States of America
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Wisconsin
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Canada
State/province [48] 0 0
Alberta
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Canada
State/province [49] 0 0
British Columbia
Country [50] 0 0
Canada
State/province [50] 0 0
Manitoba
Country [51] 0 0
Canada
State/province [51] 0 0
Nova Scotia
Country [52] 0 0
Canada
State/province [52] 0 0
Ontario
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Canada
State/province [53] 0 0
Quebec
Country [54] 0 0
Canada
State/province [54] 0 0
Saskatchewan
Country [55] 0 0
New Zealand
State/province [55] 0 0
Auckland
Country [56] 0 0
Puerto Rico
State/province [56] 0 0
San Juan

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard G Gorlick
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

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/NCT00899275