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JOURNAL ONKOLOGIE – STUDIE

Study of Kidney Tumors in Younger Patients

Rekrutierend

NCT-Nummer:
NCT00898365

Studienbeginn:
Februar 2006

Letztes Update:
09.08.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Neoplasms, Carcinoma, Renal Cell, Adenoma, Wilms Tumor, Rhabdoid Tumor, Kidney Neoplasms, Carcinoma, Medullary, Sarcoma, Clear Cell, Nephroma, Mesoblastic, Angiolipoma, Adenofibroma

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Children's Oncology Group

Collaborator:
National Cancer Institute (NCI)

Studienleiter

Elizabeth A Mullen
Principal Investigator
Children's Oncology Group

Studienlocations
(3 von 248)

University of Alabama at Birmingham Cancer Center
35233 Birmingham
United StatesAktiv, nicht rekrutierend» Google-Maps
Providence Alaska Medical Center
99508 Anchorage
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 907-212-6871
E-Mail: AKPAMC.OncologyResearchSupport@providence.org» Ansprechpartner anzeigen
University of Arkansas for Medical Sciences
72205 Little Rock
United StatesAktiv, nicht rekrutierend» Google-Maps
Children's Hospital and Research Center at Oakland
94609-1809 Oakland
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 510-428-3324
E-Mail: cgolden@mail.cho.org» Ansprechpartner anzeigen
Lucile Packard Children's Hospital Stanford University
94304 Palo Alto
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 800-694-0012
E-Mail: ccto-office@stanford.edu» Ansprechpartner anzeigen
UCSF Medical Center-Parnassus
94143 San Francisco
United StatesAktiv, nicht rekrutierend» Google-Maps
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
90502 Torrance
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 310-222-3624
E-Mail: irb@lundquist.org» Ansprechpartner anzeigen
Lee Memorial Health System
33901 Fort Myers
United StatesAktiv, nicht rekrutierend» Google-Maps
Golisano Children's Hospital of Southwest Florida
33908 Fort Myers
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 239-343-5333
E-Mail: molly.arnstrom@leehealth.org» Ansprechpartner anzeigen
University of Florida Health Science Center - Gainesville
32610 Gainesville
United StatesSchwebend» Google-Maps
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
33021 Hollywood
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 954-265-1847
E-Mail: OHR@mhs.net» Ansprechpartner anzeigen
Nemours Children's Clinic - Orlando
32806 Orlando
United StatesAktiv, nicht rekrutierend» Google-Maps
UF Cancer Center at Orlando Health
32806 Orlando
United StatesAktiv, nicht rekrutierend» Google-Maps
Nemours Children's Clinic - Pensacola
32504 Pensacola
United StatesAktiv, nicht rekrutierend» Google-Maps
Tampa General Hospital
33606 Tampa
United StatesAktiv, nicht rekrutierend» Google-Maps
Saint Joseph's Hospital/Children's Hospital-Tampa
33607 Tampa
United StatesSchwebend» Google-Maps
University of Hawaii Cancer Center
96813 Honolulu
United StatesAktiv, nicht rekrutierend» Google-Maps
Tripler Army Medical Center
96859 Honolulu
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Chicago Comprehensive Cancer Center
60637 Chicago
United StatesSchwebend» Google-Maps
Loyola University Medical Center
60153 Maywood
United StatesSchwebend» Google-Maps
Advocate Lutheran General Hospital
60068 Park Ridge
United StatesAktiv, nicht rekrutierend» Google-Maps
Riley Hospital for Children
46202 Indianapolis
United StatesSchwebend» Google-Maps
Saint Vincent Hospital and Health Care Center
46260 Indianapolis
United StatesSchwebend» Google-Maps
University of Kansas Cancer Center
66160 Kansas City
United StatesAbgeschlossen» Google-Maps
University of Kentucky/Markey Cancer Center
40536 Lexington
United StatesSchwebend» Google-Maps
Tulane University Health Sciences Center
70112 New Orleans
United StatesAktiv, nicht rekrutierend» Google-Maps
Baystate Medical Center
01199 Springfield
United StatesSchwebend» Google-Maps
UMass Memorial Medical Center - University Campus
01655 Worcester
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 508-856-3216
E-Mail: cancer.research@umassmed.edu» Ansprechpartner anzeigen
Hurley Medical Center
48503 Flint
United StatesAktiv, nicht rekrutierend» Google-Maps
Helen DeVos Children's Hospital at Spectrum Health
49503 Grand Rapids
United StatesSchwebend» Google-Maps
Kalamazoo Center for Medical Studies
49008 Kalamazoo
United StatesAktiv, nicht rekrutierend» Google-Maps
William Beaumont Hospital-Royal Oak
48073 Royal Oak
United StatesAktiv, nicht rekrutierend» Google-Maps
Children's Hospitals and Clinics of Minnesota - Minneapolis
55404 Minneapolis
United StatesSchwebend» Google-Maps
University of Mississippi Medical Center
39216 Jackson
United StatesSchwebend» Google-Maps
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
89135 Las Vegas
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 702-384-0013
E-Mail: research@sncrf.org» Ansprechpartner anzeigen
Summerlin Hospital Medical Center
89144 Las Vegas
United StatesSchwebend» Google-Maps
Saint Barnabas Medical Center
07039 Livingston
United StatesAktiv, nicht rekrutierend» Google-Maps
Saint Peter's University Hospital
08901 New Brunswick
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 732-745-8600
Phone (ext.): 6163
E-Mail: kcovert@saintpetersuh.com» Ansprechpartner anzeigen
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
08903 New Brunswick
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 732-235-8675» Ansprechpartner anzeigen
Newark Beth Israel Medical Center
07112 Newark
United StatesSchwebend» Google-Maps
Overlook Hospital
07902 Summit
United StatesAktiv, nicht rekrutierend» Google-Maps
Brooklyn Hospital Center
11201 Brooklyn
United StatesAktiv, nicht rekrutierend» Google-Maps
Roswell Park Cancer Institute
14263 Buffalo
United StatesSchwebend» Google-Maps
The Steven and Alexandra Cohen Children's Medical Center of New York
11040 New Hyde Park
United StatesSchwebend» Google-Maps
Laura and Isaac Perlmutter Cancer Center at NYU Langone
10016 New York
United StatesSchwebend» Google-Maps
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
10032 New York
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 212-305-6361
E-Mail: nr2616@cumc.columbia.edu» Ansprechpartner anzeigen
Memorial Sloan Kettering Cancer Center
10065 New York
United StatesSchwebend» Google-Maps
NYP/Weill Cornell Medical Center
10065 New York
United StatesSchwebend» Google-Maps
University of Rochester
14642 Rochester
United StatesSchwebend» Google-Maps
UNC Lineberger Comprehensive Cancer Center
27599 Chapel Hill
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 877-668-0683
E-Mail: cancerclinicaltrials@med.unc.edu» Ansprechpartner anzeigen
Novant Health Presbyterian Medical Center
28204 Charlotte
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 704-384-5369
E-Mail: nnechiporchik@novanthealth.org» Ansprechpartner anzeigen
Sanford Broadway Medical Center
58122 Fargo
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 701-323-5760
E-Mail: OncologyClinicalTrialsFargo@sanfordhealth.org» Ansprechpartner anzeigen
University of Oklahoma Health Sciences Center
73104 Oklahoma City
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 405-271-8777
E-Mail: ou-clinical-trials@ouhsc.edu» Ansprechpartner anzeigen
Legacy Emanuel Hospital and Health Center
97227 Portland
United StatesAktiv, nicht rekrutierend» Google-Maps
Lehigh Valley Hospital-Cedar Crest
18103 Allentown
United StatesSchwebend» Google-Maps
Lehigh Valley Hospital - Muhlenberg
18017 Bethlehem
United StatesSchwebend» Google-Maps
BI-LO Charities Children's Cancer Center
29605 Greenville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 864-522-2066
E-Mail: kim.williams3@prismahealth.org» Ansprechpartner anzeigen
Greenville Cancer Treatment Center
29605 Greenville
United StatesAktiv, nicht rekrutierend» Google-Maps
Sanford USD Medical Center - Sioux Falls
57117-5134 Sioux Falls
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 605-312-3320
E-Mail: OncologyClinicalTrialsSF@SanfordHealth.org» Ansprechpartner anzeigen
T C Thompson Children's Hospital
37403 Chattanooga
United StatesSchwebend» Google-Maps
Dell Children's Medical Center of Central Texas
78723 Austin
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 512-628-1902
E-Mail: TXAUS-DL-SFCHemonc.research@ascension.org» Ansprechpartner anzeigen
UT Southwestern/Simmons Cancer Center-Dallas
75390 Dallas
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 214-648-7097
E-Mail: canceranswerline@UTSouthwestern.edu» Ansprechpartner anzeigen
Brooke Army Medical Center
78234 Fort Sam Houston
United StatesSchwebend» Google-Maps
Cook Children's Medical Center
76104 Fort Worth
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 682-885-2103
E-Mail: CookChildrensResearch@cookchildrens.org» Ansprechpartner anzeigen
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 713-798-1354
E-Mail: burton@bcm.edu» Ansprechpartner anzeigen
Methodist Children's Hospital of South Texas
78229 San Antonio
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 210-575-6240
E-Mail: Vinod.GidvaniDiaz@hcahealthcare.com» Ansprechpartner anzeigen
University of Texas Health Science Center at San Antonio
78229 San Antonio
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 210-450-3800
E-Mail: phoresearchoffice@uthscsa.edu» Ansprechpartner anzeigen
Scott and White Memorial Hospital
76508 Temple
United StatesSchwebend» Google-Maps
Primary Children's Hospital
84113 Salt Lake City
United StatesSchwebend» Google-Maps
Naval Medical Center - Portsmouth
23708-2197 Portsmouth
United StatesAktiv, nicht rekrutierend» Google-Maps
Virginia Commonwealth University/Massey Cancer Center
23298 Richmond
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 804-628-1914
E-Mail: klcampbell@vcu.edu» Ansprechpartner anzeigen
Providence Sacred Heart Medical Center and Children's Hospital
99204 Spokane
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 800-228-6618
E-Mail: HopeBeginsHere@providence.org» Ansprechpartner anzeigen
Cabell-Huntington Hospital
25701 Huntington
United StatesAbgeschlossen» Google-Maps
Saint Vincent Hospital Cancer Center Green Bay
54301 Green Bay
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 920-433-8889
E-Mail: ewd_research_admin@hshs.org» Ansprechpartner anzeigen
Marshfield Medical Center-Marshfield
54449 Marshfield
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 800-782-8581
E-Mail: oncology.clinical.trials@marshfieldresearch.org» Ansprechpartner anzeigen
Royal Brisbane and Women's Hospital
4029 Herston
AustraliaAktiv, nicht rekrutierend» Google-Maps
Royal Children's Hospital-Brisbane
4029 Herston
AustraliaAktiv, nicht rekrutierend» Google-Maps
Women's and Children's Hospital-Adelaide
5006 North Adelaide
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: (08) 8161 7327
E-Mail: cywhs.oncsec@health.sa.gov.au» Ansprechpartner anzeigen
Monash Medical Center-Clayton Campus
3168 Clayton
AustraliaSchwebend» Google-Maps
Princess Margaret Hospital for Children
6008 Perth
AustraliaAktiv, nicht rekrutierend» Google-Maps
McMaster Children's Hospital at Hamilton Health Sciences
L8N 3Z5 Hamilton
CanadaSchwebend» Google-Maps
The Montreal Children's Hospital of the MUHC
H3H 1P3 Montreal
CanadaSchwebend» Google-Maps
Centre Hospitalier Universitaire Sainte-Justine
H3T 1C5 Montreal
CanadaSchwebend» Google-Maps
Allan Blair Cancer Centre
S4T 7T1 Regina
CanadaAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier Universitaire de Quebec
G1V 4G2 Quebec
CanadaSchwebend» Google-Maps
Schneider Children's Medical Center of Israel
49202 Petah Tikua
IsraelSchwebend» Google-Maps
Starship Children's Hospital
1145 Grafton
New ZealandSchwebend» Google-Maps
Wellington Children's Hospital
6002 Wellington
New ZealandAbgeschlossen» Google-Maps
San Jorge Children's Hospital
00912 San Juan
Puerto RicoSchwebend» Google-Maps
Swiss Pediatric Oncology Group - Bern
3010 Bern
SwitzerlandSchwebend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed 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.

(As of Amendment 8, this aim is limited to patients with institutionally classified Stage

I to IV focal or diffuse anaplasia identified at initial biopsy or primary nephrectomy OR

at delayed nephrectomy/second biopsy.)

II. To 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. To monitor outcome for those patients who are not eligible for a subsequent

therapeutic study.

II. To describe whether the pulmonary tumor burden correlates with outcome in Stage IV

patients.(Completed as of Amendment 7)

III. To 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. (Completed as of Amendment 7)

IV. To compare the sensitivity and specificity of preoperative abdominal CT and MRI for

the identification and differentiation of nephrogenic rests and Wilms tumor in children

with multiple renal lesions. (Completed as of Amendment 7)

V. To correlate the method of conception (natural versus assisted reproductive

technology) with the development of Wilms tumor. (Completed as of Amendment 7)

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. (Completed as of Amendment 7)

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.

Ein-/Ausschlusskriterien

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, forms, and copies of imaging studies must be available

or will become available for submission and the institution must intend on

submitting them as described in the protocol procedures

- For ALL patients, (with exception of bilateral, bilaterally predisposed,

multicentric, 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 (including from

sampled lymph nodes, if patient had upfront nephrectomy)

- * Tissue must be from diagnosis, prior to any renal tumor directed

chemotherapy or radiation (only exception is for presumed favorable

histology Wilms tumor [FHWT] patients discovered to have diffuse

anaplastic Wilms tumor [DAWT] at delayed nephrectomy and plan to enroll at

delayed nephrectomy)

- Representative formalin-fixed paraffin-embedded tissue block or if a block is

unavailable, 10 unstained slides from a representative block of tumor, if

available.

- Tissue must be from diagnosis, prior to any renal tumor directed

chemotherapy or radiation (only exception is for presumed FHWT patients

discovered to have DAWT at delayed nephrectomy and plan to enroll at

delayed nephrectomy)

- Institutional pathology report, Specimen Transmittal Form, and Pre-Treatment

Pathology Checklist

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

and Pre Treatment Imaging Checklist

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

- Institutional surgical report(s) and Pre-Treatment Surgical Checklist

- CRFs: Staging Checklist and Metastatic Disease Form (if metastatic disease is

noted on imaging)

- Patients with bilateral, bilaterally predisposed, multicentric, or

unilateral tumor in solitary kidney planning to enroll without biopsy via

imaging only - these patients will not have central review or have a risk

assignment issued, but may contribute to specimen banking for future

research. 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. The Specimen Transmittal Form and Pre

Treatment Pathology Checklist are also needed.

- Please note: if the above required items are not received within 120 days of

study enrollment, the patient will be considered off study

- 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

Studien-Rationale

Primary outcome:

1. Event-free survival (Time Frame - Up to 5 years from study enrollment):
Time from diagnosis to the earliest occurrence of disease progression (if enrolling with measurable disease), first relapse (if enrolling without measurable disease), secondary malignancy, or death. Analysis plans are specific to individual COG-approved projects and biology protocols.

2. Overall survival (Time Frame - Up to 5 years from study enrollment):
Time from diagnosis to death. Analysis plans are specific to individual COG-approved projects and biology protocols.

Secondary outcome:

1. Loss of heterozygosity (LOH testing discontinued as of April 2014) (Time Frame - Baseline):
Evaluation of LOH (1p and 16q) status was performed in select patients with newly diagnosed favorable histology Wilms Tumor during the time that AREN0532 and AREN0533 were open to enrollment, in order to direct patients to the appropriate therapeutic protocol and study arm as well as validate the markers' prognostic value.

Geprüfte Regime

  • Cytology Specimen Collection Procedure (Cytologic Sampling):
    Correlative studies
  • Laboratory Biomarker Analysis:
    Correlative studies

Quelle: ClinicalTrials.gov


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