Clinical trial · Observational
Study of Kidney Tumors in Younger Patients
Renal Tumors Classification, Biology, and Banking Study
NCT00898365CI-TRIAL-00111937completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (25)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Cystic Nephroma | Adult Cystic Nephroma | ONTOLOGY_EXACT | 0.98 |
| Anaplastic Kidney Wilms Tumor | Anaplastic Kidney Wilms Tumor | ONTOLOGY_EXACT | 0.98 |
| Angiolipoma | Angiolipoma | ONTOLOGY_EXACT | 0.98 |
| Cellular Congenital Mesoblastic Nephroma | Cellular Congenital Mesoblastic Nephroma | ONTOLOGY_EXACT | 0.98 |
| Classic Congenital Mesoblastic Nephroma | Classic Congenital Mesoblastic Nephroma | ONTOLOGY_EXACT | 0.98 |
| Clear Cell Sarcoma of the Kidney | Clear Cell Sarcoma of the Kidney | ONTOLOGY_EXACT | 0.98 |
| Congenital Mesoblastic Nephroma | Congenital Mesoblastic Nephroma | ONTOLOGY_EXACT | 0.98 |
| Cystic Partially Differentiated Kidney Nephroblastoma | Cystic Partially Differentiated Kidney Nephroblastoma |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytology Specimen Collection Procedure | Other | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-correlative (renal tumor classification, biology)
- 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)
- interventionNames
- Other: Cytology Specimen Collection Procedure
- Other: Laboratory Biomarker Analysis
Primary outcomes (2)
- measure
- Event-free survival
- timeFrame
- Up to 5 years from study enrollment
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 29 Years
Show eligibility criteria text
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 metReferences
Publications (4)
- DERIVEDMullen 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
- DERIVEDBenedetti 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
- DERIVEDBenedetti 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
- DERIVEDParsons 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