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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01314391
First received: March 11, 2011
Last updated: May 17, 2016
Last verified: May 2016
  Purpose

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.


Condition Intervention
Kidney Cancer
Renal Failure
Genetic: mutation analysis
Genetic: polymerase chain reaction
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Pilot Case-Control Study of WT1 Mutations in Wilms Tumor Patients Who Develop ESRD

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Higher incidence of ESRD in non-syndromic WT patients with germline WT1 mutations than WT patients without WT1 mutations [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Blood and Tumor tissue

Estimated Enrollment: 20
Study Start Date: August 2011
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 15 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosis of Wilms Tumor
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314391

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Vicki Huff, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01314391     History of Changes
Other Study ID Numbers: AREN11B1  COG-AREN11B1  NCI-2011-02850  AREN11B1 
Study First Received: March 11, 2011
Last Updated: May 17, 2016
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
stage I Wilms tumor
stage II Wilms tumor
stage III Wilms tumor
stage IV Wilms tumor
stage V Wilms tumor
renal failure

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Neoplasms
Carcinoma, Renal Cell
Wilms Tumor
Kidney Diseases
Urologic Diseases
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Complex and Mixed
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on August 24, 2016