Study of Kidney Tumors in Younger Patients

  • STATUS
    Recruiting
  • participants needed
    5000
  • sponsor
    Children's Oncology Group
Updated on 5 December 2020
Investigator
Joseph M. Wiley
Primary Contact
Sinai Hospital of Baltimore (7.7 mi away) Contact
+104 other location
ct scan
cancer
carcinoma
MRI
metastasis
biomarker analysis
sarcoma
kidney tumor
nephroblastoma
cytology specimen collection procedure
nephrectomy
papillary renal cell carcinoma
anaplasia
renal neoplasm
metanephric adenoma

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.

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.

Details
Treatment laboratory biomarker analysis, cytology specimen collection procedure
Clinical Study IdentifierNCT00898365
SponsorChildren's Oncology Group
Last Modified on5 December 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age less than or equal to 29 yrs?
Gender: Male or Female
Do you have any of these conditions: Stage I Wilms Tumor or Malignant neoplasm of kidney or Hereditary Cancer Syndromes or Cellular Congenital Mesoblastic Nephroma or Stage III Wilms Tumo...?
Do you have any of these conditions: Hereditary Neoplastic Syndrome or Adenocarcinoma or Angiolipoma or Kidney Medullary Carcinoma or Metanephric Tumor or Rhabdoid Tumor of the Kidney or ...?
Do you have any of these conditions: Classic Congenital Mesoblastic Nephroma or Angiolipoma or Urologic Cancer or Extrarenal Rhabdoid Tumor or Stage V Wilms Tumor or Clear Cell Sarcoma of...?
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
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