Biomarkers in Blood and Tumor Tissue Samples From Patients With Wilms Tumor

NCT ID: NCT01314391

Last Updated: 2016-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Brief Summary

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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.

Detailed Description

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OBJECTIVES:

* To determine whether Wilms Tumor (WT) patients without WT1-associated congenital anomalies or syndromes, but with end-stage renal disease (ESRD) unrelated to progressive bilateral tumors, carry germline WT1 mutations.
* To determine whether non-syndromic WT1 germline mutation carriers have a substantially higher incidence of ESRD than do WT patients who do not harbor WT1 mutations.

OUTLINE: Archived blood and tumor tissue specimens (or DNA isolated from these samples) are analyzed for WT1 mutations by gene sequencing and PCR.

Conditions

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Kidney Cancer Renal Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Interventions

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mutation analysis

Intervention Type GENETIC

polymerase chain reaction

Intervention Type GENETIC

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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
Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vicki Huff, PhD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Other Identifiers

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COG-AREN11B1

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2011-02850

Identifier Type: REGISTRY

Identifier Source: secondary_id

AREN11B1

Identifier Type: OTHER

Identifier Source: secondary_id

AREN11B1

Identifier Type: -

Identifier Source: org_study_id

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