- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00900042
SWOG-9023, DNA Analysis of Tumor Tissue From Patients With Metastatic Kidney Cancer
Cytogenetic and Flow Cytometric Analysis of : Renal Cell Carcinoma: A Companion Protocol to SWOG-8949
RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment.
PURPOSE: This laboratory study is analyzing the DNA in tumor tissue from patients with metastatic kidney cancer.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- Determine if cytogenetic abnormalities can predict clinical outcome, in terms of response to treatment and survival, in patients with metastatic renal cell carcinoma registered to the nephrectomy arm (arm I) of SWOG-8949.
- Correlate cytogenetic abnormalities and DNA content analysis (DNA index and S-phase fraction) with clinical outcome.
OUTLINE: This is a partially prospective, partially retrospective, multicenter, companion study.
Paraffin-embedded tumor tissue specimens from patients enrolled in SWOG-8949 are evaluated by cytogenetic analysis (e.g., presence of trisomy and loss of Y chromosome) and flow cytometric analysis (e.g., presence of nondiploid cells and presence of abnormal proliferation index).
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Diagnosis of renal cell carcinoma
- Any T, any N, M1 disease as specified in SWOG-8949
- Eligible for and registered on the nephrectomy arm* (arm I) of SWOG-8949 NOTE: *Patients must be registered on this study before undergoing nephrectomy on SWOG-8949
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of successes per number of evaluable samples
Time Frame: up to 4 years after registration
|
Success is defined as obtaining at least 10 analyzable metaphases.
|
up to 4 years after registration
|
Number of abnormalities per number of successes
Time Frame: up to 4 years after registration
|
Abnormality is defined as at lease one clonal chromosomal abnormality.
|
up to 4 years after registration
|
Correlation of tumor response to treatment with the type and number of abnormalities
Time Frame: up to 4 years after registration
|
Abnormality is defined as at lease one clonal chromosomal abnormality.
|
up to 4 years after registration
|
Correlation of time from diagnosis to development of metastatic disease with the type and number of abnormalities
Time Frame: up to 4 years after registration
|
Abnormality is defined as at lease one clonal chromosomal abnormality.
|
up to 4 years after registration
|
Correlation of time from first diagnosis of metastatic disease until death with the type and number of abnormalities
Time Frame: up to 4 years after registration
|
Abnormality is defined as at lease one clonal chromosomal abnormality.
|
up to 4 years after registration
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000502305
- U10CA032102 (U.S. NIH Grant/Contract)
- SWOG-9023 (Other Identifier: SWOG)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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