NCT00900042

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 1993

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1993

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

February 25, 2014

Status Verified

February 1, 2014

Enrollment Period

9.4 years

First QC Date

May 9, 2009

Last Update Submit

February 21, 2014

Conditions

Keywords

stage IV renal cell cancer

Outcome Measures

Primary Outcomes (5)

  • Number of successes per number of evaluable samples

    Success is defined as obtaining at least 10 analyzable metaphases.

    up to 4 years after registration

  • Number of abnormalities per number of successes

    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

    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

    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

    Abnormality is defined as at lease one clonal chromosomal abnormality.

    up to 4 years after registration

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Tumor diagnostic tissue

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

Cytogenetic AnalysisFlow Cytometry

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Cytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesCell SeparationCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, Analytical

Study Officials

  • Robert P. Whitehead, MD

    University of Texas

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

July 1, 1993

Primary Completion

December 1, 2002

Study Completion

January 1, 2003

Last Updated

February 25, 2014

Record last verified: 2014-02