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Gene Analysis in Studying Susceptibility to Wilms Tumor

Primary Purpose

Recurrent Childhood Kidney Neoplasm, Stage I Kidney Wilms Tumor, Stage II Kidney Wilms Tumor

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Laboratory Biomarker Analysis
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Recurrent Childhood Kidney Neoplasm

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Childrens Oncology Group

Arms of the Study

Arm 1

Arm Type

Arm Label

Ancillary-correlative (genetic markers of Wilms tumor)

Arm Description

Samples are analyzed for SNP profiling using real-time PCR and MLPA.

Outcomes

Primary Outcome Measures

Frequencies between cases and controls at each SNP
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).
Frequency of maternal and paternal allelic transmission for risk alleles
Compared using a chi-squared test.
Genetic variation on sub-phenotypes such as age at diagnosis, unilateral or bilateral disease, sex, and ethnicity
Interactions between genetic variation and treatment success or prognosis
Interactions between germline genetic variation and tumor phenotypes

Secondary Outcome Measures

Full Information

First Posted
March 6, 2013
Last Updated
August 18, 2016
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01808079
Brief Title
Gene Analysis in Studying Susceptibility to Wilms Tumor
Official Title
A Genome-Wide Association Study in Wilms Tumor
Study Type
Observational

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Childhood Kidney Neoplasm, Stage I Kidney Wilms Tumor, Stage II Kidney Wilms Tumor, Stage III Kidney Wilms Tumor, Stage IV Kidney Wilms Tumor

7. Study Design

Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ancillary-correlative (genetic markers of Wilms tumor)
Arm Description
Samples are analyzed for SNP profiling using real-time PCR and MLPA.
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Frequencies between cases and controls at each SNP
Description
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).
Time Frame
Baseline
Title
Frequency of maternal and paternal allelic transmission for risk alleles
Description
Compared using a chi-squared test.
Time Frame
Baseline
Title
Genetic variation on sub-phenotypes such as age at diagnosis, unilateral or bilateral disease, sex, and ethnicity
Time Frame
Baseline
Title
Interactions between genetic variation and treatment success or prognosis
Time Frame
Baseline
Title
Interactions between germline genetic variation and tumor phenotypes
Time Frame
Baseline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 3000 samples from the 1958 Birth Cohort (58C) and 3000 from the UK Blood Service control series (NBS)
Study Population Description
Tissue Bank
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Grundy
Organizational Affiliation
Children's Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Gene Analysis in Studying Susceptibility to Wilms Tumor

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