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.
Brief Title
Collecting and Storing Tissue, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma or Other Soft Tissue Sarcoma
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.
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.
Categories
Completion Date
Completion Date Type
Actual
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
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
* 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
Inclusion 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
* 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
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
50 Years
NCT Id
NCT00919269
Org Class
Network
Org Full Name
Children's Oncology Group
Org Study Id
D9902
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol
Primary Outcomes
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
Outcome Measure
Collection of clinical data on patients who are not being treated on a COG therapeutic study
Outcome Time Frame
Up to 10 years
Secondary Ids
Secondary Id
NCI-2009-00502
Secondary Id
IRS-D9902
Secondary Id
CCG-B904
Secondary Id
COG-D9902
Secondary Id
CDR0000078602
Secondary Id
POG-9153
Secondary Id
D9902
Secondary Id
D9902
Secondary Id
U10CA024507
Secondary Id
UG1CA189958
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
50
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Lisa Gennarini
Investigator Email
lfigueir@montefiore.org
Investigator Phone