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A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol

50 Years
Open (Enrolling)
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

Thank you

Trial Information

A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol


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

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.


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

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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

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

Outcome Time Frame:

Up to 10 years

Safety Issue:


Principal Investigator

Steve Skapek

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Oncology Group


United States: Institutional Review Board

Study ID:




Start Date:

March 1999

Completion Date:

Related Keywords:

  • 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
  • Chordoma
  • Rhabdomyosarcoma
  • Fibromatosis, Aggressive
  • Rhabdomyosarcoma, Embryonal
  • Sarcoma
  • Desmoplastic Small Round Cell Tumor



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Legacy Emanuel Hospital and Health Center Portland, Oregon  97227
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Duke University Medical Center Durham, North Carolina  27710
University of Florida Gainesville, Florida  32610-0277
University of Rochester Rochester, New York  14642
Nemours Children's Clinic - Pensacola Pensacola, Florida  32504
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University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470
M D Anderson Cancer Center Houston, Texas  77030
Seattle Children's Hospital Seattle, Washington  98105
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157
Childrens Memorial Hospital Chicago, Illinois  60614
Kaiser Permanente-Oakland Oakland, California  94611
Lombardi Comprehensive Cancer Center at Georgetown University Washington, District of Columbia  20057
M D Anderson Cancer Center- Orlando Orlando, Florida  32806
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Saint Luke's Mountain States Tumor Institute Boise, Idaho  83712
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Michigan State University - Breslin Cancer Center East Lansing, Michigan  48824-1313
Kalamazoo Center for Medical Studies Kalamazoo, Michigan  49008
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University of Minnesota Medical Center-Fairview Minneapolis, Minnesota  55455
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Walter Reed National Military Medical Center Bethesda, Maryland  20889
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