Collecting and Storing Tissue, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma or Other Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT00919269|
Recruitment Status : Active, not recruiting
First Posted : June 12, 2009
Last Update Posted : December 13, 2017
|Condition or disease||Intervention/treatment|
|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|
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.
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|
|Estimated Enrollment :||1500 participants|
|Official Title:||A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol|
|Study Start Date :||March 1999|
|Estimated Primary Completion Date :||January 2100|
|Estimated Study Completion Date :||January 2100|
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
- 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 ]
- Collection of clinical data on patients who are not being treated on a COG therapeutic study [ Time Frame: Up to 10 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919269
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|Principal Investigator:||Steve Skapek, MD||Children's Oncology Group|