Study of Kidney Tumors in Younger Patients



Status:Recruiting
Conditions:Colorectal Cancer, Cancer, Cancer, Hematology, Kidney Cancer
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any - 29
Updated:2/24/2019
Start Date:February 27, 2006

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Renal Tumors Classification, Biology, and Banking 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.

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.

Inclusion Criteria:

- Patients with the first occurrence of any tumor of the kidney identified on CT scan or
MRI are eligible for this study; histologic diagnosis is not required prior to
enrollment but is required for all patients once on study

- Eligible tumors include (but are not limited to):

- Nephroblastic tumors

- Nephroblastoma (Wilms' tumor) (favorable histology, anaplasia [diffuse,
focal])

- 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 central
nervous system [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

- Patients with the first occurrence of the following tumors are also eligible:

- Extrarenal nephroblastoma or extrarenal neprogenic rests

- Malignant rhabdoid tumor occurring anywhere outside the Central Nervous System

- Required specimens, reports, and copies of imaging studies must be available for
submission or must become available during the required timeframe

- For ALL patients (with exception of bilateral, bilaterally predisposed or unilateral
tumor in solitary kidney planning to enroll without biopsy), the following submissions
are required:

- A complete set of recut hematoxylin and eosin (H & E) slides**

- Representative formalin-fixed paraffin-embedded tissue block or if a block is
unavailable, 10 unstained slides from a representative block of tumor**

- Institutional pathology report, transmittal form and pathology checklist

- Copies of images and institutional reports of CT and/or MRI abdomen and pelvis

- Copies of images and institutional report of CT chest for all malignant tumors

- Institutional surgical report(s)

- Tissue must be from diagnosis, prior to any chemotherapy or radiation

- For patients with clinical features and required imaging findings consistent with the
eligibility for the bilateral study, AREN0534 (or successor study), confirmed by
central review, biopsy is not required; however, if biopsy is done, tissue must be
submitted as for other renal tumors, and initial risk assignment will require
pathology and surgical rapid central reviews; transmittal form and pathology checklist
are also needed

- Patients with extrarenal Wilms tumor must have tumor tissue available for central
review

- Patients with extra-CNS malignant rhabdoid tumor must have tumor tissue available for
central review

- All patients and/or their parents or legal guardians must sign a written informed
consent

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met
We found this trial at
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Lexington, Kentucky
Principal Investigator: Vlad C. Radulescu
Phone: 859-257-3379
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
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2545 Schoenersville Rd
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666 Elm Street
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1 South Prospect Street
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802-656-8990
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
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11100 Euclid Avenue
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700 Childrens Drive
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7777 Forest Ln # C840
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1200 Pleasant Street
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282 Washington St
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2500 N State St
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4015 22nd Place
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262 Danny Thomas Pl
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747 52nd St
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1717 South Orange Avenue # 100
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5153 North 9th Avenue
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620 John Paul Jones Cir
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60 Crittenden Blvd # 70
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7700 Floyd Curl Dr
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4502 Medical Drive
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3020 Childrens way
San Diego, California 92123
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34800 Bob Wilson Dr,
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40 Sunshine Cottage Road
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1600 Rockland Road
Wilmington, Delaware 19803
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1540 East Hospital Drive
Ann Arbor, Michigan 48109
(877) 475-6688
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13123 E 16th Ave
Aurora, Colorado 80045
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
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401 North Broadway
Baltimore, Maryland 21287
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489 State St
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100 E Idaho St
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Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Boston, Massachusetts 02111
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
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Massachusetts General Hospital Cancer Center An integral part of one of the world
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
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121 Dekalb Ave
Brooklyn, New York 11205
(718) 250-8000
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Chapel Hill, North Carolina 27599
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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3110 MacCorkle Avenue Southeast
Charleston, West Virginia 25304
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Charlotte, North Carolina 28204
Principal Investigator: Jessica A. Bell
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Charlotte, North Carolina 28204
Principal Investigator: Joel A. Kaplan
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Chattanooga, Tennessee 37403
Principal Investigator: Manoo G. Bhakta
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Chicago, Illinois 60614
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1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
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2049 E 100th St
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(216) 444-2200
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Columbia, Missouri 65201
Principal Investigator: Barbara A. Gruner
Phone: 573-882-7440
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5 Richland Medical Park Dr
Columbia, South Carolina 29203
(803) 434-7000
Principal Investigator: Stuart L. Cramer
Phone: 803-434-3680
Palmetto Health Richland Palmetto Health Richland, originally founded in 1892 as Columbia Hospital, has a...
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Dallas, Texas 75390
Principal Investigator: Jonathan E. Wickiser
Phone: 214-648-7097
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Dallas, TX
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Principal Investigator: Jagadeesh Ramdas
Phone: 570-271-5251
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Danville, PA
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Dayton, Ohio 45404
Principal Investigator: Ayman A. El-Sheikh
Phone: 800-228-4055
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Dayton, OH
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Denver, Colorado 80218
Principal Investigator: Jennifer J. Clark
Phone: 866-775-6246
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Denver, CO
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4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
Principal Investigator: Sureyya Savasan
Phone: 313-576-9363
Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, Michigan 48236
Principal Investigator: Adonis N. Lorenzana
Phone: 734-712-3671
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Detroit, MI
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9333 Imperial Highway
Downey, California 90242
Principal Investigator: Robert M. Cooper
Phone: 510-891-3400
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Downey, CA
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Susan G. Kreissman
Phone: 888-275-3853
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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East Lansing, Michigan 48824
Principal Investigator: Aghiad Chamdin
Phone: 517-975-9547
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East Lansing, MI
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801 Broadway North
Fargo, North Dakota 58122
Principal Investigator: Samuel O. Anim
Phone: 800-437-4010
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Fargo, ND
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1600 S Andrews Ave
Fort Lauderdale, Florida 33316
(954) 355-4400
Principal Investigator: Hector M. Rodriguez-Cortes
Phone: 954-355-5346
Broward Health Medical Center Broward Health, providing service for more than 75 years, is a...
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Fort Lauderdale, FL
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Fort Myers, Florida 33908
Principal Investigator: Emad K. Salman
Phone: 239-343-5333
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Fort Myers, FL
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Principal Investigator: Kelly L. Vallance
Phone: 682-885-2103
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Fort Worth, TX
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1600 Southwest Archer Road
Gainesville, Florida 32610
Principal Investigator: William B. Slayton
Phone: 352-273-8010
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Gainesville, FL
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835 S Van Buren St
Green Bay, Wisconsin 54301
Principal Investigator: Catherine A. Long
Phone: 920-433-8889
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Green Bay, WI
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
Principal Investigator: Andrea R. Whitfield
Phone: 252-744-1015
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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Greenville, NC
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900 West Faris Rd.
Greenville, South Carolina 29605
(864)455-8898
Principal Investigator: Nichole L. Bryant
Phone: 864-241-6251
BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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Greenville, SC
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Greenville, South Carolina 29605
Principal Investigator: Cary E. Stroud
Phone: 864-241-6251
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Burton E. Appel
Phone: 201-996-2879
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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