Renal Tumors Classification Biology and Banking Study
S
Sandeep Batra, MD
Primary Investigator
K
Kamnesh Pradhan, MD
Primary Investigator
Enrolling By Invitation
29 years or below
All
Phase
N/A
10 participants needed
3 Locations
Brief description of study
What is the purpose of this study?
This research trial studies kidney tumors in younger patients. The purpose of this study is to 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; and 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.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.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
- 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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Riley, Wilms Tumor, Clear Cell Sarcoma of the Kidney, Metanephric Tumor, Rhabdoid Tumor of the Kidney, Renal Cell Carcinoma, Cystic Partially Differentiated Kidney Nephroblastoma, Angiolipoma, Nephroma, Diffuse Hyperplastic Perilobar Nephroblastomatosis, Extrarenal Rhabdoid Tumor
-
Age: 29 years or below
-
Gender: All
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
- Nephroblastic tumors
- 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
- A complete set of recut hematoxylin and eosin (H & E) slides (including from sampled lymph nodes, if patient had upfront nephrectomy)
- 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
Updated on
11 Dec 2024.
Study ID: PHO-COG-FALLON-AREN03B2, 1010002644 (0605-02)
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