Study of Kidney Tumours in Younger Patients

Official Title

Renal Tumours Classification, Biology, and Banking Study

Summary:

This research trial studies kidney tumours in younger patients. Collecting and storing samples of tumour 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.

Trial Description

Primary Outcome:

• Event-free survival
• Overall survival

Secondary Outcome:

• Loss of heterozygosity (LOH testing discontinued as of April 2014)

PRIMARY OBJECTIVES:

• Classify patients with renal tumours by histological categorization, surgico-pathological stage, presence of metastases, age at diagnosis, tumour 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)
• 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:

• Monitor outcome for those patients who are not eligible for a subsequent therapeutic study including patients initially classified as Low Risk, defined as those with favourable histology Wilms tumour Stage I (> 2 years old or tumour weight > 550 g) or Stage II whose final risk classification is Low Risk and whose tumours do not have LOH 1p and 16q.
• Describe whether the pulmonary tumour burden correlates with outcome in stage IV patients. (Completed as of Amendment 7)
• Describe the sensitivity and specificity of abdominal computed tomography (CT) by comparison with surgical and pathologic findings for identification of local tumour spread beyond the renal capsule to adjacent muscle and organs, lymph node involvement at the renal hilum and in the retroperitoneum, preoperative tumour rupture, and metastases to the liver. (Completed as of Amendment 7)
• 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' tumour in children with multiple renal lesions. (Completed as of Amendment 7)
• Correlate the method of conception (natural vs assisted reproductive technology) with the development of Wilms' tumour. (Completed as of Amendment 7)
• To evaluate the frequency of integrase interactor 1 (INI1) mutations in renal and extrarenal malignant rhabdoid tumour of the kidney and to determine the incidence of germline and inherited versus somatic mutations to facilitate clinical correlations on the companion study AREN0321. (INI1 testing discontinued as of April 2014) (Completed as of Amendment 7)

OUTLINE:
Tumour tissue, blood, and urine samples are collected for research studies, including immunohistochemistry. CT scans and MRIs are also performed. Loss of heterozygosity analyses (chromosome 1p and 16q) are performed by extraction of DNA. DNA polymorphisms are assayed by polymerase chain reaction using standard methodology. Leftover specimens are archived for future studies. (LOH and INI1 testing discontinued as of April 2014) Patients are followed up periodically for 5 years.

View this trial on ClinicalTrials.gov