Study of Kidney Tumors in Young Patients
This laboratory study is looking at kidney tumors in young 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. It may also help the study of cancer in the future.
Clear Cell Sarcoma of the Kidney
Congenital Mesoblastic Nephroma
Diffuse Hyperplastic Perilobar Nephroblastomatosis
Rhabdoid Tumor of the Kidney
Stage I Renal Cell Cancer
Stage I Wilms Tumor
Stage II Renal Cell Cancer
Stage II Wilms Tumor
Stage III Renal Cell Cancer
Stage III Wilms Tumor
Stage IV Renal Cell Cancer
Stage IV Wilms Tumor
Stage V Wilms Tumor
Other: laboratory biomarker analysis
Other: cytology specimen collection procedure
|Study Design:||Time Perspective: Prospective|
|Official Title:||Renal Tumors Classification, Biology, and Banking Study|
- Disease-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Loss of heterozygosity [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Tumor tissue, blood, and urine samples
|Study Start Date:||February 2006|
|Estimated Primary Completion Date:||January 2100 (Final data collection date for primary outcome measure)|
Tumor 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.
Other: laboratory biomarker analysis
Correlative studiesOther: cytology specimen collection procedure
Other Name: cytologic sampling
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.
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.
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 patients with stage IV disease.
III. Describe the sensitivity and specificity of abdominal computed tomography (CT) scan by comparing it 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 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.
OUTLINE: This is a multicenter study.
Tumor tissue, blood, and urine samples are collected for research studies, including immunohistochemistry. CT scans and magnetic resonance imaging (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.
Patients are followed periodically for 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898365
Show 219 Study Locations
|Principal Investigator:||Elizabeth Mullen||Children's Oncology Group|