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

Brief Title

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

Official Title

A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol

Brief 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.
    


Study Type

Observational


Primary Outcome

Collection of human tumor tissue and other biological specimens (blood, serum, and bone marrow) from patients with rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma


Condition

Adult Rhabdomyosarcoma

Intervention

Cytology Specimen Collection Procedure

Study Arms / Comparison Groups

 Ancillary-Correlative (specimen collection)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

150

Start Date

March 15, 1999



Eligibility 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
      

Gender

All

Ages

N/A - 50 Years

Accepts Healthy Volunteers

No

Contacts

Stephen Skapek, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT00919269

Organization ID

D9902

Secondary IDs

NCI-2009-00502

Responsible Party

Sponsor

Study Sponsor

Children's Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Stephen Skapek, Principal Investigator, Children's Oncology Group


Verification Date

March 2021