NCT00919269

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
OTHER	Cytology Specimen Collection Procedure	Correlative studies
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 1999-03-15
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2009-06-12
• Last updated: 2023-10-03

Locations

247 sites across 7 countries: United States, Australia, Canada, Netherlands, New Zealand, Puerto Rico, Switzerland