NCT00908739

Brief Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at tumor tissue samples from patients who have undergone surgery for localized kidney cancer.

Trial Health

10
At Risk

Trial Health Score

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

Status
withdrawn

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

May 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
Last Updated

September 30, 2015

Status Verified

September 1, 2015

Enrollment Period

4 months

First QC Date

May 23, 2009

Last Update Submit

September 29, 2015

Conditions

Kidney Cancer

Keywords

stage I renal cell cancerstage III renal cell cancerrecurrent renal cell cancerclear cell renal cell carcinomachildhood renal cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • Relative patterns of expression/activity of five different growth factors/enzymes inherently related to the development of metastatic renal cell carcinoma behavior

Interventions

gene expression analysisGENETIC

immunohistochemistry for levels of expression of five different factors related to aggressive tumor behavior (i.e., VEGF expression, E-cadherin regulation, matrix metalloproteinase 2 and 9 activity, and carbonic anhydrase 9 activity)

immunohistochemistry staining methodOTHER

immunohistochemistry for levels of expression of five different factors related to aggressive tumor behavior (i.e., VEGF expression, E-cadherin regulation, matrix metalloproteinase 2 and 9 activity, and carbonic anhydrase 9 activity)

laboratory biomarker analysisOTHER

immunohistochemistry for levels of expression of five different factors related to aggressive tumor behavior (i.e., VEGF expression, E-cadherin regulation, matrix metalloproteinase 2 and 9 activity, and carbonic anhydrase 9 activity)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care clinic

DISEASE CHARACTERISTICS: * Tumor tissue samples from patients who recently underwent nephrectomy or partial nephrectomy for clear cell renal cell carcinoma * Harvested from the superior, inferior, left lateral, right lateral, and central portions of resected or discarded tumor measuring 4 cm or less * Localized disease (pT1a, N0-Nx, M0) 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

Previously collected tumor tissue samples are examined by immunohistochemistry for levels of expression of five different factors related to aggressive tumor behavior (i.e., VEGF expression, E-cadherin regulation, matrix metalloproteinase 2 and 9 activity, and carbonic anhydrase 9 activity.

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

Gene Expression ProfilingImmunohistochemistry

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)

Genetic TechniquesInvestigative TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesImmunologic Techniques

Study Officials

  • David A. Levy, MD

    Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 23, 2009

First Posted

May 27, 2009

Study Start

May 1, 2008

Primary Completion

September 1, 2008

Last Updated

September 30, 2015

Record last verified: 2015-09