NCT01542333

Brief Summary

RATIONALE: Studying samples of tissue and urine from patients with cancer in the laboratory may help doctor learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms tumor.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 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

February 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

4.2 years

First QC Date

February 22, 2012

Last Update Submit

May 17, 2016

Conditions

Keywords

recurrent Wilms tumor and other childhood kidney tumorsstage I Wilms tumorstage II Wilms tumorstage III Wilms tumorstage IV Wilms tumorstage V Wilms tumor

Outcome Measures

Primary Outcomes (2)

  • Molecular "finger print" of primary Wilms tumor in ethnically diverse children

  • Protein "finger print" from the urine of ethnically diverse children

Interventions

Eligibility Criteria

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

Diagnosed with Wilms tumor

DISEASE CHARACTERISTICS: * Diagnosed with Wilms tumor * Specimens from African-American and from Caucasian children * Specimens from each ethnicity who relapsed * Specimens from each ethnicity who did NOT relapse PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

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

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney NeoplasmsWilms Tumor

Interventions

Gene Expression ProfilingReverse Transcriptase Polymerase Chain ReactionBlotting, WesternImmunohistochemistrySpectrum Analysis

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification TechniquesElectrophoresisChemistry Techniques, AnalyticalElectrochemical TechniquesImmunoblottingImmunoassayImmunologic TechniquesMolecular Probe TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological Techniques

Study Officials

  • Harold N. Lovvorn, III, MD

    Vanderbilt Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2012

First Posted

March 2, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05