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.
Brief Title
Study of Kidney Tumors in Younger Patients
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.
(As of Amendment 8, this aim is limited to patients with institutionally classified Stage I to IV focal or diffuse anaplasia identified at initial biopsy or primary nephrectomy OR at delayed nephrectomy/second biopsy.)
II. 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.
SECONDARY OBJECTIVES:
I. To monitor outcome for those patients who are not eligible for a subsequent therapeutic study.
II. To describe whether the pulmonary tumor burden correlates with outcome in Stage IV patients.(Completed as of Amendment 7)
III. To 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. To compare the sensitivity and specificity of preoperative abdominal CT and MRI for the identification and differentiation of nephrogenic rests and Wilms tumor in children with multiple renal lesions. (Completed as of Amendment 7)
V. To correlate the method of conception (natural versus 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. (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.
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.
(As of Amendment 8, this aim is limited to patients with institutionally classified Stage I to IV focal or diffuse anaplasia identified at initial biopsy or primary nephrectomy OR at delayed nephrectomy/second biopsy.)
II. 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.
SECONDARY OBJECTIVES:
I. To monitor outcome for those patients who are not eligible for a subsequent therapeutic study.
II. To describe whether the pulmonary tumor burden correlates with outcome in Stage IV patients.(Completed as of Amendment 7)
III. To 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. To compare the sensitivity and specificity of preoperative abdominal CT and MRI for the identification and differentiation of nephrogenic rests and Wilms tumor in children with multiple renal lesions. (Completed as of Amendment 7)
V. To correlate the method of conception (natural versus 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. (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.
Categories
Conditions
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
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
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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
29 Years
NCT Id
NCT00898365
Org Class
Network
Org Full Name
Children's Oncology Group
Org Study Id
AREN03B2
Overall Status
Active, not recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Renal Tumors Classification, Biology, and Banking Study
Primary Outcomes
Outcome 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.
Outcome Measure
Event-free survival
Outcome Time Frame
Up to 5 years from study enrollment
Outcome Description
Time from diagnosis to death. Analysis plans are specific to individual COG-approved projects and biology protocols.
Outcome Measure
Overall survival
Outcome Time Frame
Up to 5 years from study enrollment
Secondary Ids
Secondary Id
NCI-2009-00416
Secondary Id
COG-AREN03B2
Secondary Id
CDR0000459797
Secondary Id
AREN03B2
Secondary Id
AREN03B2
Secondary Id
U10CA180886
Secondary Id
U10CA098543
Secondary Id
UG1CA189958
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Baseline
Outcome Measure
Loss of heterozygosity (LOH testing discontinued as of April 2014)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Patients newly diagnosed with kidney tumors
Std Ages
Child
Adult
Locked Fields
Render the field
Maximum Age Number (converted to Years and rounded down)
29
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Lisa Gennarini
Investigator Email
lfigueir@montefiore.org