Study of Kidney Tumors in Young Patients
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Purpose
RATIONALE: 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 DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future.
PURPOSE: This laboratory study is looking at kidney tumors in young patients.
| Condition | Intervention |
|---|---|
|
Kidney Cancer Nonneoplastic Condition |
Genetic: loss of heterozygosity analysis Genetic: polymerase chain reaction Genetic: polymorphism analysis Other: immunohistochemistry staining method Procedure: computed tomography Procedure: magnetic resonance imaging |
| Study Type: | Observational |
| Official Title: | Renal Tumors Classification, Biology, and Banking Study |
- 10-year disease-free survival [ Designated as safety issue: No ]
- 10-year overall survival [ Designated as safety issue: No ]
- Loss of heterozygosity [ Designated as safety issue: No ]
| Study Start Date: | February 2006 |
OBJECTIVES:
Primary
- 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.
- 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
- Monitor outcome for those patients who are not eligible for a subsequent therapeutic study.
- Describe whether the pulmonary tumor burden correlates with outcome in patients with stage IV disease.
- Describe the sensitivity and specificity of abdominal 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.
- 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.
- 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 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.
PROJECTED ACCRUAL: There are no sample size goals for this study.
Eligibility| Ages Eligible for Study: | up to 29 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of renal tumors, including any of the following:
Nephroblastic tumors
Nephroblastoma (Wilms' tumor) (favorable histology, anaplasia [diffuse, focal])
- Patients with extra-renal nephroblastoma allowed
- Nephrogenic rests and nephroblastomatosis
- Cystic nephroma and cystic partially differentiated nephroblastoma
- Metanephric tumors (metanephric adenoma, metanephric adenofibroma, metanephric stromal tumor)
- Mesoblastic nephroma (cellular, classic, mixed)
- Clear cell sarcoma
- Rhabdoid tumor (any malignant rhabdoid tumor occurring outside the CNS)
- Renal epithelioid tumors of childhood (papillary renal cell carcinoma, medullary renal cell carcinoma, renal tumors associated with Xp11.2 translocations, oncocytic renal neoplasms after neuroblastoma)
- Angiolipoma
- Ossifying renal tumor of infancy
- Newly diagnosed disease
- Paraffin-embedded tumor samples requested and available
- Blood samples available
- Urine samples requested and available
- Copies of imaging studies available
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- No prior therapy for cancer
Contacts and Locations
Show 215 Study Locations| Study Chair: | Paul E. Grundy, MD | Stollery Children's Hospital at University of Alberta Hospital |
| Investigator: | Jeffrey S. Dome, MD | St. Jude Children's Research Hospital |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00898365 History of Changes |
| Other Study ID Numbers: | CDR0000459797, COG-AREN03B2 |
| Study First Received: | May 9, 2009 |
| Last Updated: | November 22, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage I Wilms tumor stage II Wilms tumor stage III Wilms tumor stage IV Wilms tumor stage V Wilms tumor clear cell sarcoma of the kidney rhabdoid tumor of the kidney |
stage I renal cell cancer stage II renal cell cancer stage III renal cell cancer stage IV renal cell cancer congenital mesoblastic nephroma diffuse hyperplastic perilobar nephroblastomatosis |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013