Last updated on April 2019

Study of Kidney Tumors in Younger Patients


Brief description of study

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 Study Description

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) mutations in renal and extrarenal malignant rhabdoid tumor 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)

OUTLINE

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. (LOH and INI1 testing discontinued as of April 2014)

Patients are followed up periodically for 5 years.

Clinical Study Identifier: NCT00898365

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Inova Fairfax Hospital

Falls Church, VA United States
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Florida Hospital Orlando

Orlando, FL United States
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University of Virginia Cancer Center

Charlottesville, VA United States
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Cleveland Clinic Foundation

Cleveland, OH United States
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Kaiser Permanente-Oakland

Oakland, CA United States
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Mount Sinai Hospital

New York, NY United States
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Sinai Hospital of Baltimore

Baltimore, MD United States
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Ochsner Medical Center Jefferson

New Orleans, LA United States
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Saint Peter's University Hospital

New Brunswick, NJ United States
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Saint Mary's Hospital

West Palm Beach, FL United States
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Children's Hospital of Alabama

Birmingham, AL United States
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Phoenix Childrens Hospital

Phoenix, AZ United States
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Arkansas Children's Hospital

Little Rock, AR United States
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Children's Hospital Los Angeles

Los Angeles, CA United States
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Mattel Children's Hospital UCLA

Los Angeles, CA United States
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Santa Barbara Cottage Hospital

Santa Barbara, CA United States
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Yale University

New Haven, CT United States
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Broward Health Medical Center

Fort Lauderdale, FL United States
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Lee Memorial Health System

Fort Myers, FL United States
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Nemours Children's Hospital

Orlando, FL United States
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Tripler Army Medical Center

Honolulu, HI United States
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University of Illinois

Chicago, IL United States
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Riley Hospital for Children

Indianapolis, IN United States
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Blank Children's Hospital

Des Moines, IA United States
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Maine Children's Cancer Program

Scarborough, ME United States
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Baystate Medical Center

Springfield, MA United States
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C S Mott Children's Hospital

Ann Arbor, MI United States
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Hurley Medical Center

Flint, MI United States
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Bronson Methodist Hospital

Kalamazoo, MI United States
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Mayo Clinic

Rochester, MN United States
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Columbia Regional

Columbia, MO United States
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The Childrens Mercy Hospital

Kansas City, MO United States
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Saint Barnabas Medical Center

Livingston, NJ United States
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Overlook Hospital

Summit, NJ United States
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Albany Medical Center

Albany, NY United States
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Brooklyn Hospital Center

Brooklyn, NY United States
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University of Rochester

Rochester, NY United States
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New York Medical College

Valhalla, NY United States
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East Carolina University

Greenville, NC United States
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Mercy Children's Hospital

Toledo, OH United States
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Geisinger Medical Center

Danville, PA United States
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Rhode Island Hospital

Providence, RI United States
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Palmetto Health Richland

Columbia, SC United States
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T C Thompson Children's Hospital

Chattanooga, TN United States
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Driscoll Children's Hospital

Corpus Christi, TX United States
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Brooke Army Medical Center

Fort Sam Houston, TX United States
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Cook Children's Medical Center

Fort Worth, TX United States
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M D Anderson Cancer Center

Houston, TX United States
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Primary Children's Hospital

Salt Lake City, UT United States
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Seattle Children's Hospital

Seattle, WA United States
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Marshfield Clinic

Marshfield, WI United States
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Christchurch Hospital

Christchurch, New Zealand
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Cedars Sinai Medical Center

Los Angeles, CA United States
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UCSF Medical Center-Parnassus

San Francisco, CA United States
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UCSF Medical Center-Mission Bay

San Francisco, CA United States
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Miami Cancer Institute

Miami, FL United States
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Johns Hopkins All Children's Hospital

Saint Petersburg, FL United States
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Tampa General Hospital

Tampa, FL United States
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Norton Children's Hospital

Louisville, KY United States
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Children's Hospital New Orleans

New Orleans, LA United States
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Mercy Hospital Saint Louis

Saint Louis, MO United States
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Morristown Medical Center

Morristown, NJ United States
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NYU Winthrop Hospital

Mineola, NY United States
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University Medical Center

Lubbock, TX United States
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Cabell-Huntington Hospital

Huntington, WV United States
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John Hunter Children's Hospital

New Lambton Heights, Australia
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Recruitment Status: Open


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