AREN03B2 Renal Tumors Classification, Biology, and Banking Study
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Other
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
Unspecified
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Keywords
- 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
Contact Us
(410) 955-8964Brief Summary
We would like to have some of the tumor from your biopsy and/or surgery for this study. If your tumor returns after treatment, we would like to have some of that tumor tissue also. In addition, the AREN03B2 study surgeons would like to evaluate the information in the surgical reports from your hospital.
â?¢ Blood will be taken for testing during your routine care. We would like to have about three extra teaspoonfuls of blood drawn when blood is drawn for routine tests. If you require further therapy, we would also like to have about two extra teaspoonfuls of blood when blood is taken at the end of all your therapy for your routine care, and a year after that, when blood is taken for your routine follow-up care.
â?¢ Urine will be collected for testing during your routine care. We would like to have some of the urine collected (about two teaspoonfuls) for research tests.
You will have studies done to find out the size of your tumor and its exact location in your body (CT, MRI, Ultrasound) during your routine care. We would like to have copies of these studies and reports sent to a central review center where the information will be used to make sure you are given the best treatment for your disease. Then study doctors will also use the information to decide which kind of imaging studies give the
best information about the tumor.
Eligibility
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