NCT01576198

Brief Summary

RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in the laboratory may help doctors to 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
2,227

participants targeted

Target at 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

April 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

4.3 years

First QC Date

April 11, 2012

Last Update Submit

July 13, 2016

Conditions

Kidney Cancer

Keywords

Wilms tumor and other childhood kidney tumors

Outcome Measures

Primary Outcomes (1)

  • Validation of copy number changes (gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q) in FHWT by the MLPA assay

Interventions

DNA analysisGENETIC
nucleic acid amplificationGENETIC
diagnostic 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 Wilms Tumor

DISEASE CHARACTERISTICS: * DNA samples from FHWT patients registered on: * NWTS-4 * NWTS-5 with focal and diffuse anaplasia tumors 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

Nucleic Acid Amplification Techniques

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 Techniques

Study Officials

  • Elizabeth J. Perlman, MD

    Ann & Robert H Lurie Children's Hospital of Chicago

    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

April 11, 2012

First Posted

April 12, 2012

Study Start

April 1, 2012

Primary Completion

July 1, 2016

Last Updated

July 14, 2016

Record last verified: 2016-07