Gene Analysis in Studying Susceptibility to Wilms Tumor

Completed

• Conditions: Stage II Kidney Wilms Tumor; Stage III Kidney Wilms Tumor; Stage IV Kidney Wilms Tumor; Recurrent Childhood Kidney Neoplasm; Stage I Kidney Wilms Tumor
• Interventions: Other: Laboratory Biomarker Analysis

• Registration Number: NCT01808079
• Lead Sponsor: Children's Oncology Group

Brief Summary

This clinical trial studies gene analysis in studying susceptibility to Wilms tumor. Finding genetic markers for Wilms tumor may help identify patients who are at risk of relapse.

Detailed Description

PRIMARY OBJECTIVES:

I. To use a genome-wide association analysis to identify novel genetic variants that confer susceptibility to Wilms tumor.

II. To improve our understanding of the genetic architecture and etiology of Wilms tumor.

III. To facilitate the identification of genetic markers that are associated with an increased risk of developing of Wilms tumor and/or those at risk of aggressive disease, relapse, additional tumors and/or cancer in their offspring.

OUTLINE:

Samples are analyzed for single nucleotide polymorphism (SNP) profiling using real-time polymerase chain reaction (PCR) and multiplex ligation-dependent probe amplification (MLPA).

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Study First Submitted: 2013-03-06
• Study First Submitted QC: 2013-03-07
• Study First Posted: 2013-03-11
• Status Verified: 2016-07
• Last Update Submitted: 2016-08-18
• Last Update Posted: 2016-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• 3000 samples from the 1958 Birth Cohort (58C) and 3000 from the UK Blood Service control series (NBS)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-correlative (genetic markers of Wilms tumor)	Laboratory Biomarker Analysis	Samples are analyzed for SNP profiling using real-time PCR and MLPA.

Primary Outcome Measures

Name	Time	Method
Frequency of maternal and paternal allelic transmission for risk alleles	Baseline	Compared using a chi-squared test.
Interactions between genetic variation and treatment success or prognosis	Baseline
Interactions between germline genetic variation and tumor phenotypes	Baseline
Genetic variation on sub-phenotypes such as age at diagnosis, unilateral or bilateral disease, sex, and ethnicity	Baseline
Frequencies between cases and controls at each SNP	Baseline	Compared using the Cochran Armitage trend test (1-df). The data will be analyzed individually for the UK/US study populations and combined using a Mantel-Haenszel analysis adjusting for study group, and related methods which allow for different effects in each population (for confirmed loci, we will compare effects across populations).

Trial Locations

Locations (1)

Childrens Oncology Group; 🇺🇸 Philadelphia, Pennsylvania, United States