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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00919269
First received: June 11, 2009
Last updated: August 12, 2014
Last verified: August 2014

June 11, 2009
August 12, 2014
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 ] [ Designated as safety issue: No ]
  • Collection of clinical data on patients who are not being treated on a COG therapeutic study [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Collection of human tumor tissue and other biological specimens (blood, serum, and bone marrow) from patients with rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma [ Designated as safety issue: No ]
  • Collection of clinical data on patients who are not being treated on a COG therapeutic study [ Designated as safety issue: No ]
  • Creation of a repository for storage of tissue and other biological specimens collected by COG investigators [ Designated as safety issue: No ]
  • Making these specimens available for approved projects by laboratory-based investigators [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Comparison of the clinical, cytogenetic, and molecular biologic features of patient subgroups with anaplastic rhabdomyosarcoma and other subtypes of rhabdomyosarcoma [ Designated as safety issue: No ]
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
Not Provided
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
Both
up to 50 Years
No
United States,   Canada,   New Zealand,   Australia,   Puerto Rico,   Switzerland
 
NCT00919269
D9902, NCI-2009-00502, IRS-D9902, CCG-B904, COG-D9902, CDR0000078602, POG-9153, U10CA024507
No
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
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP