Trial Information

A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol

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.