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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00919269
Recruitment Status : Active, not recruiting
First Posted : June 12, 2009
Last Update Posted : October 14, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Tracking Information
First Submitted Date June 11, 2009
First Posted Date June 12, 2009
Last Update Posted Date October 14, 2019
Actual Study Start Date March 15, 1999
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: June 13, 2013)
  • 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 ]
  • Collection of clinical data on patients who are not being treated on a COG therapeutic study [ Time Frame: Up to 10 years ]
Original Primary Outcome Measures
 (submitted: June 11, 2009)
  • Collection of human tumor tissue and other biological specimens (blood, serum, and bone marrow) from patients with rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma
  • Creation of a repository for storage of tissue and other biological specimens collected by COG investigators
  • Making these specimens available for approved projects by laboratory-based investigators
  • Collection of clinical data on patients who are not being treated on a COG therapeutic study
  • Definition and comparison of clinical features of patient subgroups with alveolar rhabdomyosarcoma whose tumors carry the t(2;13), t(1;13) or neither translocation
  • Relationship between submicroscopic alveolar rhabdomyosarcoma disease and CR/PR rates, failure-free survival, survival by positive or negative RT-PCR assay for t(2:13) and t(1:13) on peripheral blood and bone marrow specimens at diagnosis
  • Comparison of the clinical, cytogenetic, and molecular biologic features of patient subgroups with anaplastic rhabdomyosarcoma and other subtypes of rhabdomyosarcoma
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collecting and Storing Tissue, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma or Other Soft Tissue Sarcoma
Official Title A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol
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.
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 Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Not Provided
Condition
  • 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
Intervention
  • Other: Cytology Specimen Collection Procedure
    Correlative studies
    Other Name: Cytologic Sampling
  • Other: Laboratory Biomarker Analysis
    Correlative studies
Study Groups/Cohorts 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.
Interventions:
  • Other: Cytology Specimen Collection Procedure
  • Other: Laboratory Biomarker Analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: August 3, 2018)
150
Original Enrollment Not Provided
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 50 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Canada,   Netherlands,   New Zealand,   Puerto Rico,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number 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 )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Children's Oncology Group
Study Sponsor Children's Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Stephen Skapek Children's Oncology Group
PRS Account Children's Oncology Group
Verification Date October 2019