SWOG-9023, DNA Analysis of Tumor Tissue From Patients With Metastatic Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

Cytogenetic and Flow Cytometric Analysis of : Renal Cell Carcinoma: A Companion Protocol to SWOG-8949

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900042
• Other study ID #: CDR0000502305
• Secondary ID: SWOG-9023U10CA03
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: February 21, 2014
• Start date: July 1993
• Est. completion date: January 2003

Study information

• Verified date: February 2014
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 2003
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Genetic:
• DNA ploidy analysis

• DNA stability analysis

• chromosomal translocation analysis

• cytogenetic analysis

Other:
• flow cytometry

• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of successes per number of evaluable samples	Success is defined as obtaining at least 10 analyzable metaphases.	up to 4 years after registration	No
Primary	Number of abnormalities per number of successes	Abnormality is defined as at lease one clonal chromosomal abnormality.	up to 4 years after registration	No
Primary	Correlation of tumor response to treatment with the type and number of abnormalities	Abnormality is defined as at lease one clonal chromosomal abnormality.	up to 4 years after registration	No
Primary	Correlation of time from diagnosis to development of metastatic disease with the type and number of abnormalities	Abnormality is defined as at lease one clonal chromosomal abnormality.	up to 4 years after registration	No
Primary	Correlation of time from first diagnosis of metastatic disease until death with the type and number of abnormalities	Abnormality is defined as at lease one clonal chromosomal abnormality.	up to 4 years after registration	No