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Collecting and Storing Tissue, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma or Other Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT00919269
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : October 3, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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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.

Condition or disease Intervention/treatment
Adult Rhabdomyosarcoma Childhood Desmoplastic Small Round Cell Tumor Chordoma Desmoid-Type Fibromatosis Metastatic Childhood Soft Tissue Sarcoma Non-Metastatic Childhood Soft Tissue Sarcoma Previously Treated Childhood Rhabdomyosarcoma Recurrent Adult Soft Tissue Sarcoma Recurrent Childhood Rhabdomyosarcoma Recurrent Childhood Soft Tissue Sarcoma Rhabdomyosarcoma Stage I Adult Soft Tissue Sarcoma AJCC v7 Stage II Adult Soft Tissue Sarcoma AJCC v7 Stage III Adult Soft Tissue Sarcoma AJCC v7 Stage IV Adult Soft Tissue Sarcoma AJCC v7 Untreated Childhood Rhabdomyosarcoma Other: Cytology Specimen Collection Procedure Other: Laboratory Biomarker Analysis

Detailed Description:

PRIMARY OBJECTIVES:

I. Collect human tumor tissue and other biological specimens (blood, serum, and bone marrow) from patients with rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma diagnosed and/or treated at a Children's Oncology Group (COG) member institution.

II. Provide a repository for storage of tissue and other biological specimens collected by COG investigators from these patients.

III. Make these specimens available for approved projects by laboratory-based investigators.

IV. Collect clinical data on these patients who are not being treated on a COG therapeutic study.

V. Define and compare the clinical features of patient subgroups with alveolar rhabdomyosarcoma whose tumors carry the t(2;13), t(1;13) or neither translocation.

VI. Investigate the relationship between evidence of submicroscopic disease and response rate (CR/PR), failure-free survival, and survival of patients with alveolar rhabdomyosarcoma, as determined by positive or negative reverse transcriptase-polymerase chain reaction (RT-PCR) assay for the t(2:13) and t(1:13) on peripheral blood and bone marrow specimens obtained at diagnosis.

VII. Compare the clinical, cytogenetic, and molecular biologic features of patient subgroups with anaplastic rhabdomyosarcoma and other subtypes of rhabdomyosarcoma.

OUTLINE:

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.

Patients who are not enrolled on a Children's Oncology Group treatment trial are followed every 6 months for at least 10 years or until disease progression or development of a second malignancy.

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Official Title: A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol
Actual Study Start Date : March 15, 1999
Actual Primary Completion Date : September 30, 2023
Actual Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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: Cytology Specimen Collection Procedure
Correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. Collection of human tumor tissue and other biological specimens (blood, serum, and bone marrow) from patients with rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma [ Time Frame: Up to 10 years ]
  2. Collection of clinical data on patients who are not being treated on a COG therapeutic study [ Time Frame: Up to 10 years ]

Eligibility Criteria
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Ages Eligible for Study:   up to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919269


Locations
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Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Stephen Skapek Children's Oncology Group
More Information
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00919269    
Other Study ID Numbers: D9902
NCI-2009-00502 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IRS-D9902
CCG-B904
COG-D9902
CDR0000078602
POG-9153
D9902 ( Other Identifier: Childrens Oncology Group )
D9902 ( Other Identifier: CTEP )
U10CA024507 ( U.S. NIH Grant/Contract )
UG1CA189958 ( U.S. NIH Grant/Contract )
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: October 3, 2023
Last Verified: October 2023
Additional relevant MeSH terms:
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Sarcoma
Rhabdomyosarcoma
Rhabdomyosarcoma, Embryonal
Fibromatosis, Aggressive
Chordoma
Desmoplastic Small Round Cell Tumor
Fibroma
Recurrence
Disease Attributes
 Pathologic Processes
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Germ Cell and Embryonal