Clinical Trial: Study of Kidney Tumors in Younger Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Renal Tumors Classification, Biology, and Banking Study

Brief Summary: This research trial studies kidney tumors in younger patients. Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Detailed Summary:

PRIMARY OBJECTIVES:

I. Classify patients with renal tumors by histological categorization, surgico-pathological stage, presence of metastases, age at diagnosis, tumor weight, and loss of heterozygosity for chromosomes 1p and 16q, to define eligibility for a series of therapeutic studies. (Loss of heterozygosity [LOH] testing discontinued as of April 2014) II. Maintain a biological samples bank to make specimens available to scientists to evaluate additional potential biological prognostic variables and for the conduct of other research by scientists.

SECONDARY OBJECTIVES:

I. Monitor outcome for those patients who are not eligible for a subsequent therapeutic study.

II. Describe whether the pulmonary tumor burden correlates with outcome in stage IV patients.

III. Describe the sensitivity and specificity of abdominal computed tomography (CT) by comparison with surgical and pathologic findings for identification of local tumor spread beyond the renal capsule to adjacent muscle and organs, lymph node involvement at the renal hilum and in the retroperitoneum, preoperative tumor rupture, and metastases to the liver.

IV. Compare the sensitivity and specificity of pre-operative abdominal CT scan and magnetic resonance imaging (MRI) for the identification and differentiation of nephrogenic rests and Wilms' tumor in children with multiple renal lesions.

V. Correlate the method of conception (natural vs assisted reproductive technology) with the development of Wilms' tumor.

VI. To evaluate the frequency of integrase interactor 1 (INI1) mut
Sponsor: Children's Oncology Group

Current Primary Outcome:

  • Disease-free survival [ Time Frame: Up to 5 years ]
  • Overall survival [ Time Frame: Up to 5 years ]


Original Primary Outcome:

  • 10-year disease-free survival
  • 10-year overall survival


Current Secondary Outcome: Loss of heterozygosity (LOH testing discontinued as of April 2014) [ Time Frame: Up to 5 years ]

Original Secondary Outcome: Loss of heterozygosity

Information By: Children's Oncology Group

Dates:
Date Received: May 9, 2009
Date Started: February 2006
Date Completion:
Last Updated: November 18, 2016
Last Verified: November 2016