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Trial record 2 of 2 for:    COG D9902

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

This study is currently recruiting participants.
Verified September 2017 by Children's Oncology Group
Sponsor:
ClinicalTrials.gov Identifier:
NCT00919269
First Posted: June 12, 2009
Last Update Posted: September 27, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
June 11, 2009
June 12, 2009
September 27, 2017
March 1999
January 2100   (Final data collection date for primary outcome measure)
  • 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 ]
  • 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
Complete list of historical versions of study NCT00919269 on ClinicalTrials.gov Archive Site
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Collecting and Storing Tissue, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma or Other Soft Tissue Sarcoma
A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
human tumor tissue and other biological specimens (blood, serum, and bone marrow)
Non-Probability Sample
Patients planning to be enrolled on a front-line COG RMS or NRSTS therapeutic study, patients planning to be enrolled on a front-line COG RMS or NRSTS therapeutic study and patients NOT planning to be enrolled on a front-line COG RMS or NRSTS therapeutic study.
  • Adult Rhabdomyosarcoma
  • Childhood Desmoplastic Small Round Cell Tumor
  • Chordoma
  • Desmoid Tumor
  • Metastatic Childhood Soft Tissue Sarcoma
  • Nonmetastatic Childhood Soft Tissue Sarcoma
  • Previously Treated Childhood Rhabdomyosarcoma
  • Previously Untreated Childhood Rhabdomyosarcoma
  • Recurrent Adult Soft Tissue Sarcoma
  • Recurrent Childhood Rhabdomyosarcoma
  • Recurrent Childhood Soft Tissue Sarcoma
  • Stage I Adult Soft Tissue Sarcoma
  • Stage II Adult Soft Tissue Sarcoma
  • Stage III Adult Soft Tissue Sarcoma
  • Stage IV Adult Soft Tissue Sarcoma
  • Other: biologic sample preservation procedure
  • Other: laboratory biomarker analysis
    Correlative studies
Observational
Perform biologic sample preservation procedure - 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 laboratory biomarker analysis - 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: biologic sample preservation procedure
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
January 2100
January 2100   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 50 Years   (Child, Adult)
No
Australia,   Canada,   New Zealand,   Puerto Rico,   Switzerland,   United States
Netherlands
 
NCT00919269
D9902
NCI-2009-00502 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IRS-D9902 ( Other Identifier: Intergroup Rhabdosarcoma Group )
CCG-B904 ( Other Identifier: Children's Cancer Group )
COG-D9902 ( Other Identifier: Children's Oncology Group )
CDR0000078602 ( Other Identifier: Clinical Trials.gov )
POG-9153 ( Other Identifier: Pediatric Oncology Group )
U10CA024507 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Steve Skapek, MD Children's Oncology Group
Children's Oncology Group
September 2017