Trial record 1 of 1 for:    POG D9902
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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 February 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: February 12, 2014
Last verified: February 2014
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

human tumor tissue and other biological specimens (blood, serum, and bone marrow)


Estimated Enrollment: 1500
Study Start Date: March 1999
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: biologic sample preservation procedure Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919269

  Show 220 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Steve Skapek, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00919269     History of Changes
Other Study ID Numbers: D9902, NCI-2009-00502, IRS-D9902, CCG-B904, COG-D9902, CDR0000078602, POG-9153, U10CA024507
Study First Received: June 11, 2009
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chordoma
Rhabdomyosarcoma
Fibromatosis, Aggressive
Rhabdomyosarcoma, Embryonal
Sarcoma
Desmoplastic Small Round Cell Tumor
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on July 28, 2014