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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00919269




Registration number
NCT00919269
Ethics application status
Date submitted
11/06/2009
Date registered
11/06/2009
Date last updated
3/08/2018

Titles & IDs
Public title
Collecting and Storing Tissue, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma or Other Soft Tissue Sarcoma
Scientific title
A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol
Secondary ID [1] 0 0
NCI-2009-00502
Secondary ID [2] 0 0
D9902
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adult Rhabdomyosarcoma 0 0
Childhood Desmoplastic Small Round Cell Tumor 0 0
Chordoma 0 0
Desmoid-Type Fibromatosis 0 0
Metastatic Childhood Soft Tissue Sarcoma 0 0
Non-Metastatic Childhood Soft Tissue Sarcoma 0 0
Previously Treated Childhood Rhabdomyosarcoma 0 0
Recurrent Adult Soft Tissue Sarcoma 0 0
Recurrent Childhood Rhabdomyosarcoma 0 0
Recurrent Childhood Soft Tissue Sarcoma 0 0
Rhabdomyosarcoma 0 0
Stage I Adult Soft Tissue Sarcoma AJCC v7 0 0
Stage II Adult Soft Tissue Sarcoma AJCC v7 0 0
Stage III Adult Soft Tissue Sarcoma AJCC v7 0 0
Stage IV Adult Soft Tissue Sarcoma AJCC v7 0 0
Untreated Childhood Rhabdomyosarcoma 0 0
Adult Rhabdomyosarcoma 0 0
Childhood Desmoplastic Small Round Cell Tumor 0 0
Chordoma 0 0
Desmoid-Type Fibromatosis 0 0
Metastatic Childhood Soft Tissue Sarcoma 0 0
Non-Metastatic Childhood Soft Tissue Sarcoma 0 0
Previously Treated Childhood Rhabdomyosarcoma 0 0
Recurrent Adult Soft Tissue Sarcoma 0 0
Recurrent Childhood Rhabdomyosarcoma 0 0
Recurrent Childhood Soft Tissue Sarcoma 0 0
Rhabdomyosarcoma 0 0
Stage I Adult Soft Tissue Sarcoma AJCC v7 0 0
Stage II Adult Soft Tissue Sarcoma AJCC v7 0 0
Stage III Adult Soft Tissue Sarcoma AJCC v7 0 0
Stage IV Adult Soft Tissue Sarcoma AJCC v7 0 0
Untreated Childhood Rhabdomyosarcoma 0 0
Adult Rhabdomyosarcoma 0 0
Childhood Desmoplastic Small Round Cell Tumor 0 0
Chordoma 0 0
Desmoid-Type Fibromatosis 0 0
Metastatic Childhood Soft Tissue Sarcoma 0 0
Non-Metastatic Childhood Soft Tissue Sarcoma 0 0
Previously Treated Childhood Rhabdomyosarcoma 0 0
Recurrent Adult Soft Tissue Sarcoma 0 0
Recurrent Childhood Rhabdomyosarcoma 0 0
Recurrent Childhood Soft Tissue Sarcoma 0 0
Rhabdomyosarcoma 0 0
Stage I Adult Soft Tissue Sarcoma AJCC v7 0 0
Stage II Adult Soft Tissue Sarcoma AJCC v7 0 0
Stage III Adult Soft Tissue Sarcoma AJCC v7 0 0
Stage IV Adult Soft Tissue Sarcoma AJCC v7 0 0
Untreated Childhood Rhabdomyosarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Children's - Other
Cancer 0 0 0 0
Other cancer types

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
Other interventions - Laboratory Biomarker Analysis
Other interventions - Cytology Specimen Collection Procedure
Other interventions - Laboratory Biomarker Analysis
Other interventions - Cytology Specimen Collection Procedure
Other interventions - Laboratory Biomarker Analysis

Ancillary-Correlative (specimen collection) - Surgical tissue, bone marrow, and blood specimens are collected at diagnosis (initial or relapse) and, if applicable, at the development of a second primary tumor. Specimens are used for research purposes. A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute.

Ancillary-Correlative (specimen collection) - Surgical tissue, bone marrow, and blood specimens are collected at diagnosis (initial or relapse) and, if applicable, at the development of a second primary tumor. Specimens are used for research purposes. A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute.

Ancillary-Correlative (specimen collection) - Surgical tissue, bone marrow, and blood specimens are collected at diagnosis (initial or relapse) and, if applicable, at the development of a second primary tumor. Specimens are used for research purposes. A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute.


Other interventions: Cytology Specimen Collection Procedure
Correlative studies

Other interventions: Laboratory Biomarker Analysis
Correlative studies

Other interventions: Cytology Specimen Collection Procedure
Correlative studies

Other interventions: Laboratory Biomarker Analysis
Correlative studies

Other interventions: Cytology Specimen Collection Procedure
Correlative studies

Other interventions: Laboratory Biomarker Analysis
Correlative studies

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Collection of human tumor tissue and other biological specimens (blood, serum, and bone marrow) from patients with rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma
Timepoint [1] 0 0
Up to 10 years
Primary outcome [2] 0 0
Collection of clinical data on patients who are not being treated on a COG therapeutic study
Timepoint [2] 0 0
Up to 10 years
Primary outcome [3] 0 0
Collection of human tumor tissue and other biological specimens (blood, serum, and bone marrow) from patients with rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma
Timepoint [3] 0 0
Up to 10 years
Primary outcome [4] 0 0
Collection of clinical data on patients who are not being treated on a COG therapeutic study
Timepoint [4] 0 0
Up to 10 years
Primary outcome [5] 0 0
Collection of human tumor tissue and other biological specimens (blood, serum, and bone marrow) from patients with rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma
Timepoint [5] 0 0
Up to 10 years
Primary outcome [6] 0 0
Collection of clinical data on patients who are not being treated on a COG therapeutic study
Timepoint [6] 0 0
Up to 10 years

Eligibility
Key inclusion criteria
- Histologically or cytologically confirmed diagnosis of 1 of the following:

- Rhabdomyosarcoma

- Non-rhabdomyosarcoma soft tissue sarcoma

- Chordoma

- Desmoid fibromatosis

- Desmoplastic round cell tumors

- Undifferentiated embryonal sarcoma of the liver

- Unclassified soft tissue sarcoma that is too undifferentiated to be placed in a
specific pathologic category in the WHO classification (often called
?undifferentiated soft tissue sarcoma? or ?soft tissue sarcoma NOS?)

- Other soft tissue neoplasms, excluding benign tumors

- Must have pathological specimens of tumor-containing tissue or bone marrow (beyond
that needed by the institution for diagnosis) available for study

- No malignant rhabdoid tumor, Ewing sarcoma/primitive neuroectodermal tumor, or
osteogenic sarcoma of bone

- No osteogenic sarcoma
Minimum age
No limit
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Children's Hospital - Hunter Regional Mail Centre
Recruitment hospital [2] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [3] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [5] 0 0
Royal Children's Hospital-Brisbane - Herston
Recruitment hospital [6] 0 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [7] 0 0
Women's and Children's Hospital-Adelaide - North Adelaide
Recruitment hospital [8] 0 0
Monash Medical Center-Clayton Campus - Clayton
Recruitment hospital [9] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [10] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2310 - Hunter Regional Mail Centre
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
5006 - North Adelaide
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3052 - Parkville
Recruitment postcode(s) [9] 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
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
State/province [11] 0 0
Hawaii
Country [12] 0 0
United States of America
State/province [12] 0 0
Idaho
Country [13] 0 0
United States of America
State/province [13] 0 0
Illinois
Country [14] 0 0
United States of America
State/province [14] 0 0
Indiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Iowa
Country [16] 0 0
United States of America
State/province [16] 0 0
Kansas
Country [17] 0 0
United States of America
State/province [17] 0 0
Kentucky
Country [18] 0 0
United States of America
State/province [18] 0 0
Louisiana
Country [19] 0 0
United States of America
State/province [19] 0 0
Maine
Country [20] 0 0
United States of America
State/province [20] 0 0
Maryland
Country [21] 0 0
United States of America
State/province [21] 0 0
Massachusetts
Country [22] 0 0
United States of America
State/province [22] 0 0
Michigan
Country [23] 0 0
United States of America
State/province [23] 0 0
Minnesota
Country [24] 0 0
United States of America
State/province [24] 0 0
Mississippi
Country [25] 0 0
United States of America
State/province [25] 0 0
Missouri
Country [26] 0 0
United States of America
State/province [26] 0 0
Nebraska
Country [27] 0 0
United States of America
State/province [27] 0 0
Nevada
Country [28] 0 0
United States of America
State/province [28] 0 0
New Hampshire
Country [29] 0 0
United States of America
State/province [29] 0 0
New Jersey
Country [30] 0 0
United States of America
State/province [30] 0 0
New Mexico
Country [31] 0 0
United States of America
State/province [31] 0 0
New York
Country [32] 0 0
United States of America
State/province [32] 0 0
North Carolina
Country [33] 0 0
United States of America
State/province [33] 0 0
North Dakota
Country [34] 0 0
United States of America
State/province [34] 0 0
Ohio
Country [35] 0 0
United States of America
State/province [35] 0 0
Oklahoma
Country [36] 0 0
United States of America
State/province [36] 0 0
Oregon
Country [37] 0 0
United States of America
State/province [37] 0 0
Pennsylvania
Country [38] 0 0
United States of America
State/province [38] 0 0
Rhode Island
Country [39] 0 0
United States of America
State/province [39] 0 0
South Carolina
Country [40] 0 0
United States of America
State/province [40] 0 0
South Dakota
Country [41] 0 0
United States of America
State/province [41] 0 0
Tennessee
Country [42] 0 0
United States of America
State/province [42] 0 0
Texas
Country [43] 0 0
United States of America
State/province [43] 0 0
Utah
Country [44] 0 0
United States of America
State/province [44] 0 0
Vermont
Country [45] 0 0
United States of America
State/province [45] 0 0
Virginia
Country [46] 0 0
United States of America
State/province [46] 0 0
Washington
Country [47] 0 0
United States of America
State/province [47] 0 0
West Virginia
Country [48] 0 0
United States of America
State/province [48] 0 0
Wisconsin
Country [49] 0 0
Canada
State/province [49] 0 0
Alberta
Country [50] 0 0
Canada
State/province [50] 0 0
British Columbia
Country [51] 0 0
Canada
State/province [51] 0 0
Manitoba
Country [52] 0 0
Canada
State/province [52] 0 0
Newfoundland and Labrador
Country [53] 0 0
Canada
State/province [53] 0 0
Nova Scotia
Country [54] 0 0
Canada
State/province [54] 0 0
Ontario
Country [55] 0 0
Canada
State/province [55] 0 0
Quebec
Country [56] 0 0
Canada
State/province [56] 0 0
Saskatchewan
Country [57] 0 0
Netherlands
State/province [57] 0 0
Nijmegen
Country [58] 0 0
New Zealand
State/province [58] 0 0
Auckland
Country [59] 0 0
New Zealand
State/province [59] 0 0
Christchurch
Country [60] 0 0
Puerto Rico
State/province [60] 0 0
San Juan
Country [61] 0 0
Switzerland
State/province [61] 0 0
Bern
Country [62] 0 0
Switzerland
State/province [62] 0 0
Geneva
Country [63] 0 0
Switzerland
State/province [63] 0 0
Lausanne

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
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Cancer Institute (NCI)
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
National Cancer Institute (NCI)
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to collect and store tumor tissue, blood, and bone marrow
samples from patients with soft tissue sarcoma that will be tested in the laboratory.
Collecting and storing samples of tumor tissue, blood, and bone marrow from patients to test
in the laboratory may help the study of cancer.
Trial website
https://clinicaltrials.gov/show/NCT00919269
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Skapek
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
Other publications