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

February 21, 2014 updated by: Southwest Oncology Group

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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

34

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1993

Primary Completion (Actual)

December 1, 2002

Study Completion (Actual)

January 1, 2003

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

February 25, 2014

Last Update Submitted That Met QC Criteria

February 21, 2014

Last Verified

February 1, 2014

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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