NCT01550393

Brief Summary

RATIONALE: Studying samples of urine from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer. PURPOSE: This clinical trial studies biomarkers in urine from patients with Wilms tumor.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-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

March 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

4.3 years

First QC Date

March 6, 2012

Last Update Submit

July 7, 2016

Conditions

Kidney Cancer

Keywords

stage II Wilms tumorstage III Wilms tumorrecurrent Wilms tumor and other childhood kidney tumors

Outcome Measures

Primary Outcomes (1)

  • Wilms tumor biomarkers identified by ELISA

Interventions

proteomic profilingGENETIC
enzyme-linked immunosorbent assayOTHER
laboratory biomarker analysisOTHER
medical chart reviewOTHER

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with stage II-III Wilms tumors

DISEASE CHARACTERISTICS: * Urine specimens collected at diagnosis will be selected from patients with stage II-III Wilms tumors, with both local and non-local sites of disease relapse * Clinical patient information (urinalysis/macro, age, gender, congenital defects/syndromes, comorbidities, tumor stage, size, pathology, therapy, outcome) available 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

Biospecimen

Retention: SAMPLES WITH DNA

Urine

MeSH Terms

Conditions

Kidney NeoplasmsWilms Tumor

Interventions

Enzyme-Linked Immunosorbent Assay

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)

Immunoenzyme TechniquesImmunoassayImmunologic TechniquesInvestigative TechniquesImmunosorbent TechniquesImmunohistochemistryMolecular Probe Techniques

Study Officials

  • Elizabeth A. Mullen, MD

    Dana-Farber Cancer Institute

    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

March 6, 2012

First Posted

March 12, 2012

Study Start

March 1, 2012

Primary Completion

July 1, 2016

Last Updated

July 11, 2016

Record last verified: 2016-07