NCT01314391

Brief Summary

RATIONALE: Studying samples of blood and 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 studying biomarkers in blood and tumor tissue samples from 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
4.8 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

4.8 years

First QC Date

March 11, 2011

Last Update Submit

May 17, 2016

Conditions

Kidney CancerRenal Failure

Keywords

stage I Wilms tumorstage II Wilms tumorstage III Wilms tumorstage IV Wilms tumorstage V Wilms tumorrenal failure

Outcome Measures

Primary Outcomes (1)

  • Higher incidence of ESRD in non-syndromic WT patients with germline WT1 mutations than WT patients without WT1 mutations

Interventions

mutation analysisGENETIC
polymerase chain reactionGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Diagnosis of Wilms Tumor

DISEASE CHARACTERISTICS: * Diagnosis of Wilms Tumor (WT) * Patients who participated in the NWTS-5 protocol * Non-syndromic patients who developed end-stage renal disease (ESRD) during 5-10 years for reasons other than progressive bilateral WT * Matched control patients who had not developed ESRD by the time (since WT onset) of ESRD diagnosis * Blood and tumor tissue samples 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

Blood and Tumor tissue

MeSH Terms

Conditions

Kidney NeoplasmsRenal InsufficiencyWilms Tumor

Interventions

Polymerase Chain Reaction

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)

Nucleic Acid Amplification TechniquesGenetic TechniquesInvestigative Techniques

Study Officials

  • Vicki Huff, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 14, 2011

Study Start

August 1, 2011

Primary Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05