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Study of Kidney Tumors in Younger Patients

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ClinicalTrials.gov Identifier: NCT00898365
Recruitment Status : Recruiting
First Posted : May 12, 2009
Last Update Posted : November 27, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Tracking Information
First Submitted Date May 9, 2009
First Posted Date May 12, 2009
Last Update Posted Date November 27, 2020
Actual Study Start Date February 27, 2006
Estimated Primary Completion Date January 1, 2100   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 7, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: May 9, 2009)
  • 10-year disease-free survival
  • 10-year overall survival
Change History
Current Secondary Outcome Measures
 (submitted: August 7, 2020)
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.
Original Secondary Outcome Measures
 (submitted: May 9, 2009)
Loss of heterozygosity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Kidney Tumors in Younger Patients
Official Title Renal Tumors Classification, Biology, and Banking Study
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. (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. (Completed as of Amendment 7) 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. (Completed as of Amendment 7) 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. (Completed as of Amendment 7) V. Correlate the method of conception (natural vs 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. (INI1 testing discontinued as of April 2014) (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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tumor, blood, and urine samples
Sampling Method Non-Probability Sample
Study Population Patients newly diagnosed with kidney tumors
Condition
  • Adult Cystic Nephroma
  • Anaplastic Kidney Wilms Tumor
  • Angiolipoma
  • Cellular Congenital Mesoblastic Nephroma
  • Classic Congenital Mesoblastic Nephroma
  • Clear Cell Sarcoma of the Kidney
  • Congenital Mesoblastic Nephroma
  • Cystic Partially Differentiated Kidney Nephroblastoma
  • Diffuse Hyperplastic Perilobar Nephroblastomatosis
  • Extrarenal Rhabdoid Tumor
  • Kidney Medullary Carcinoma
  • Kidney Neoplasm
  • Kidney Oncocytoma
  • Kidney Wilms Tumor
  • Metanephric Adenofibroma
  • Metanephric Adenoma
  • Metanephric Stromal Tumor
  • Metanephric Tumor
  • Mixed Congenital Mesoblastic Nephroma
  • Ossifying Renal Tumor of Infancy
  • Papillary Renal Cell Carcinoma
  • Renal Cell Carcinoma
  • Renal Cell Carcinoma Associated With Xp11.2 Translocations/TFE3 Gene Fusions
  • Rhabdoid Tumor of the Kidney
  • Wilms Tumor
Intervention
  • Other: Cytology Specimen Collection Procedure
    Correlative studies
    Other Name: Cytologic Sampling
  • Other: Laboratory Biomarker Analysis
    Correlative studies
Study Groups/Cohorts Ancillary-correlative (renal tumor classification, biology)
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)
Interventions:
  • Other: Cytology Specimen Collection Procedure
  • Other: Laboratory Biomarker Analysis
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 7, 2020)
5000
Original Enrollment Not Provided
Study Completion Date Not Provided
Estimated Primary Completion Date January 1, 2100   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 29 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Australia,   Canada,   Israel,   New Zealand,   Puerto Rico,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00898365
Other Study ID Numbers AREN03B2
NCI-2009-00416 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-AREN03B2
CDR0000459797
AREN03B2 ( Other Identifier: Children's Oncology Group )
AREN03B2 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
UG1CA189958 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Children's Oncology Group
Study Sponsor Children's Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Elizabeth A Mullen Children's Oncology Group
PRS Account Children's Oncology Group
Verification Date September 2020