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NCT00898365 · CITED IN SOURCE DOCUMENTS

Study of Kidney Tumors in Younger Patients

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
Not reported
Status at capture
COMPLETED
Registry last update
2026-05-18

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
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
healthy Volunteers
false
maximum Age
29 Years
sampling Method
NON_PROBABILITY_SAMPLE
sex
ALL
std Ages
  1. CHILD
  2. ADULT
study Population
Patients newly diagnosed with kidney tumors
Treatment arms and interventions
arm Groups
  1. description
    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)
    intervention Names
    1. Other: Cytology Specimen Collection Procedure
    2. Other: Laboratory Biomarker Analysis
    label
    Ancillary-correlative (renal tumor classification, biology)
interventions
  1. arm Group Labels
    1. Ancillary-correlative (renal tumor classification, biology)
    description
    Correlative studies
    name
    Cytology Specimen Collection Procedure
    other Names
    1. Cytologic Sampling
    type
    OTHER
  2. arm Group Labels
    1. Ancillary-correlative (renal tumor classification, biology)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
Study design
observational Model
CASE_ONLY
time Perspective
PROSPECTIVE
Enrollment
count
8000
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Event-free survival
    time Frame
    Up to 5 years from study enrollment
  2. description
    Time from diagnosis to death. Analysis plans are specific to individual COG-approved projects and biology protocols.
    measure
    Overall survival
    time Frame
    Up to 5 years from study enrollment
secondary Outcomes
  1. description
    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.
    measure
    Loss of heterozygosity (LOH testing discontinued as of April 2014)
    time Frame
    Baseline
Full study description
brief Summary
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 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.
Source references
references
  1. citation
    Mullen EA, Renfro LA, Ehrlich PF, Khanna G, Treece AL, Gratias EJ, Cost NG, Grundy PE, Fernandez CV, Dome JS, Geller JI; AREN03B2 Study Committee. Feasibility of Real-Time Central Risk Assignment for Children's Oncology Group Pediatric Renal Tumor Trials. Pediatr Blood Cancer. 2026 Aug 27:e70639. doi: 10.1002/1545-5017.70639. Online ahead of print.
    pmid
    42657661
    type
    DERIVED
  2. citation
    Benedetti DJ, Renfro LA, Tfirn I, Daw NC, Kalapurakal JA, Ehrlich PF, Khanna G, Perlman E, Warwick A, Gow KW, Paulino AC, Seibel NL, Grundy P, Fernandez CV, Geller JI, Mullen EA, Dome JS. Treatment and outcomes of clear cell sarcoma of the kidney: A report from the Children's Oncology Group studies AREN0321 and AREN03B2. Cancer. 2024 Jul 1;130(13):2361-2371. doi: 10.1002/cncr.35266. Epub 2024 Feb 23.
    pmid
    38396300
    type
    DERIVED
  3. citation
    Benedetti DJ, Varela CR, Renfro LA, Tornwall B, Dix DB, Ehrlich PF, Glick RD, Kalapurakal J, Perlman E, Gratias E, Seibel NL, Geller JI, Khanna G, Malogolowkin M, Grundy P, Fernandez CV, Dome JS, Mullen EA. Treatment of children with favorable histology Wilms tumor with extrapulmonary metastases: A report from the COG studies AREN0533 and AREN03B2 and NWTSG study NWTS-5. Cancer. 2024 Mar 15;130(6):947-961. doi: 10.1002/cncr.35099. Epub 2023 Nov 7.
    pmid
    37933882
    type
    DERIVED
  4. citation
    Parsons LN, Mullen EA, Geller JI, Chi YY, Khanna G, Glick RD, Aldrink JH, Vallance KL, Kim Y, Fernandez CV, Dome JS, Perlman EJ. Outcome analysis of stage I epithelial-predominant favorable-histology Wilms tumors: A report from Children's Oncology Group study AREN03B2. Cancer. 2020 Jun 15;126(12):2866-2871. doi: 10.1002/cncr.32855. Epub 2020 Apr 8.
    pmid
    32267967
    type
    DERIVED
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        have right-sided and large tumors, as noted in a review of cases of intraoperative spill among 1,131 patients registered on COG study <a href="/clinicaltrials/NCT00898365">AREN03B2</a> (NCT00898365).[<a href="#cit/section_2.230">230</a>]</li><li>Even if stage IV disease (e.g., pulmonary metastases) is evident on imaging, resecti
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        lymph nodes sampled. Patients with stage IV disease were treated with a carboplatin-containing regimen. There were 50 patients in the <a href="/clinicaltrials/NCT00898365">AREN03B2 (NCT00898365)</a> study who were treated with the same stage-appropriate therapy. The results from the two studies are as follows:[<a href="#cit/sect
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    Preserved source evidence · Independent clinical review pending · Not medical advice