MDACC Study Summary CCG99-D9902

Study Summary
No. CCG99-D9902:.......Laboratory; Pediatrics; Sarcoma......Winston Huh......Pediatrics

Study Summary Title



Study Summary Number:	CCG99-D9902

Study Title:	A COG Protocol for Diagnosis, Collecting and Banking Soft Tissue Sarcoma Specimens

Physician

New Patient Referral



Name:	Winston Huh	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Pediatrics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6620 Contact us about clinical trials

General Information



Disease Group:	Laboratory Pediatrics Sarcoma	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Not applicable

Treatment Agents:	None	Home Care:	Not applicable

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Not applicable

Description/
Intervention:

The purpose of this laboratory research study is to collect samples from
patients with RMS, NRSTS, and other types of soft tissue sarcoma for research,
in order to find out the exact type of soft tissue sarcoma that they have, to
better understand these tumors, and to find the best treatment for the tumors.
Another goal is to study the samples to see if there is specific genetic
information in the tumor cells and the normal tissue, blood, serum, and bone
marrow of patients with these tumors that will tell researchers about the
tumors and how patients will respond to treatment. Researchers would also like
to collect a small amount of information about the treatment these patients
receive that may tell researchers about the tumors and how patients will react
to treatment.

Study Objectives / Outcomes

9. To ensure that patients with soft tissue sarcomas are enrolled on the appropriate clinical trial and that each patient is assigned to the appropriate treatment arm based on the tumor histologic subtype and/or grade, as appropriate. Prior to enrollment on a Children's Oncology Group (COG) RMS or NRSTS therapeutic soft tissue sarcoma protocol, patients must enroll on D9902 for central pathology review to determine if their tumor meets eligibility requirements.

10.

To assess the correlation between the diagnosis and histologic grade (for NRSTS cases) assigned by the enrolling institution and that established by central expert pathology reviewers. The extent of diagnostic discrepancy between institutional diagnosis and central pathology review diagnosis will be assessed to help determine whether central pathology review is warranted in future studies of childhood soft tissue sarcoma.

11. To determine which grading system (POG or FNCLCC) better predicts outcome in childhood
NRSTS.

12. To determine whether pathologic response in childhood STS is correlated with radiographic
response, and to assess whether pathologic response is predictive of outcome.

13. To evaluate childhood STS specimens obtained at the time of tumor recurrence to identify
pathologic differences compared with the initial diagnostic specimen.

Study Status Information



Study Activation / Registration Date:	12/09/1999

IRB Review and Approval Date:	03/14/2006

Study Type:	Laboratory

Recruitment Status:	Closed

Projected Accrual:	150 per year (Only applicable for Multicenter or Cooperative Group Studies).

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) </= 50 years of age at time of enrollment.

2) Patients must have one of the following histologically-confirmed diagnoses: 1) Rhabdomyosarcoma (RMS); 2) Non-rhabdomyosarcoma soft tissue sarcoma (NRSTS); 3) 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"); or, 4) other soft tissue neoplasms listed in Appendices I and II, excluding benign tumors. Diagnosis must be established by pathologic examination of tissue or bone marrow prior to study enrollment.

3) All pathology material required for participation on Central Review and/or Biology/Banking strata must be available and the institution must be committed to submitting it to the Biopathology Center (BPC) as described in the protocol procedures. Patients are only eligible for Central Review (Categories 1 and 2) if the investigator plans to also enroll the patient on a front-line COG RMS or NRSTS therapeutic study. If the patient will not be treated on a front-line COG RMS or NRSTS therapeutic study, the patient is only eligible for participation in the Biology/Banking stratum (Category 3).

4) All patients and/or their parents or legal guardians must sign a written informed consent.

5) All institutional, FDA, and NCI requirements for human studies must be met.

Exclusion Criteria:

1) >/= 50 years of age at time of enrollment.

2) Patients who have malignant rhabdoid tumor, Ewings Sarcoma/PNET, or osteogenic sarcoma of bone.

Links

Registration Number: NCT00919269
Study Information on Clinical Trials Registry (clinicaltrials.gov)