Kidney Cancer Clinical Trial
Identification of Novel High Quality Methylated DNA Markers in Renal Tumors: Whole Methylome Discovery, Tissue Validation, and Feasibility Testing In Blood and Urine, The INQUIRE Study
Summary
This study is being done to collect blood, tissue and urine samples to identify a novel high quality methylated DNA marker in patients with renal tumors.
Full Description
PRIMARY OBJECTIVES:
I. In tissue, to discover and validate DNA methylation markers (MDMs) for detection of malignant renal and urothelial tumors.
II. In blood, to assess the accuracy of candidate MDMs from above for detection of malignant renal and urothelial tumors.
OUTLINE: This is an observational study.
Participants may undergo blood, urine, and tissue sample collection on study. Participants' medical records are also reviewed.
Eligibility Criteria
Inclusion Criteria:
CASE TISSUE:
Patient has a histological diagnosis of primary clear cell RCC, papillary cell RCC, clear cell papillary RCC, chromophobe RCC, oncocytoma, or urothelial cell carcinoma
Age >= 18 years
CASE BLOODS AND URINE:
Patient has a histological diagnosis of primary clear cell RCC, papillary cell RCC, chromophobe RCC, oncocytoma, or urothelial cell carcinoma
Age >= 18 years
HEALTHY CONTROL BLOODS AND URINE:
Patients has undergone negative hematuria workups (defined as negative abdominal imaging and negative cystoscopy
Age >= 18 years
Exclusion Criteria:
CASE TISSUE:
Patient has von Hippel-Lindau disease (VHL), Hereditary leiomyomatosis and renal cell cancer (HLRCC), Hereditary papillary renal carcinoma (HPRC), or Birt-Hogg-Dube syndrome (BHD)
The current target pathology is a recurrence
Patient has undergone any prior radiation therapy to target lesion prior to surgery
Patient has received chemotherapy class drugs in the 5 years prior to surgery
Patient has had any transplants prior to surgery
Patient has confirmation of Lynch Syndrome, is presumed to have Lynch Syndrome, or has familial cancer syndrome X
Patient has Nephritis (Glomerulus or Interstitial), Poly Cystic Kidney Disease, Glomerulonephropathies or Acquired Renal Kidney Disease
RENAL CONTROL TISSUE:
Patient has von Hippel-Lindau disease (VHL), Hereditary leiomyomatosis and renal cell cancer (HLRCC), Hereditary papillary renal carcinoma (HPRC), or Birt-Hogg-Dube syndrome (BHD).
Patient has inflammation, atypia, or hyperplasia of the parenchyma
Patient has a current or past history of renal cancer.
Patient has undergone any prior radiation therapy to target lesion prior to surgery
Patient has received chemotherapy class drugs in the 5 years prior to surgery
Patient has had any transplants prior to surgery
Patient has confirmation of Lynch Syndrome, is presumed to have Lynch Syndrome, or has familial cancer syndrome X
Patient has Nephritis (Glomerulus or Interstitial), Poly Cystic Kidney Disease, Glomerulonephropathies or Acquired Renal Kidney Disease
UROTHELIEAL CONTROL TISSUE:
Patient has von Hippel-Lindau disease (VHL), Hereditary leiomyomatosis and renal cell cancer (HLRCC), Hereditary papillary renal carcinoma (HPRC), or Birt-Hogg-Dubé syndrome (BHD)
Patient has inflammation, atypia, or hyperplasia of the urothelium
Patient has a current or past history of urothelial cancer
Patient has undergone any prior radiation therapy to target lesion prior to surgery
Patient has received chemotherapy class drugs in the 5 years prior to surgery
Patient has had any transplants prior to surgery
Patient has confirmed or presumed lynch
CASE BLOODS AND URINE:
Patient has known primary cancer outside of the kidney within the last 5 years prior to plasma and urine collection (not including basal cell or squamous cell skin cancers)
Patient has had surgery to completely or partially remove current target pathology
Patient has undergone any prior radiation therapy to target lesion prior to plasma and urine collection
Patient has received chemotherapy class drugs in the 5 years prior to plasma and urine collection
Patient has had any transplants prior to plasma and urine collection
Patient has confirmed or presumed lynch
Patient has von Hippel-Lindau disease (VHL), Hereditary leiomyomatosis and renal cell cancer (HLRCC), Hereditary papillary renal carcinoma (HPRC), or Birt-Hogg-Dubé syndrome (BHD)
HEALTHY CONTROL BLOODS AND URINE:
Patient has known primary cancer outside of the urothelium within the last 5 years prior to plasma and urine collection (not including basal cell or squamous cell skin cancers)
Current target pathology is a recurrence
Patient has undergone prior radiation therapy in the 5 years prior to plasma and urine collection
Patient has received chemotherapy class drugs in the 5 years prior to plasma and urine collection
Patient has had any transplants prior to plasma and urine collection
Patient has von Hippel-Lindau disease (VHL), Hereditary leiomyomatosis and renal cell cancer (HLRCC), Hereditary papillary renal carcinoma (HPRC), or Birt-Hogg-Dube syndrome (BHD)
Patient has confirmed or presumed lynch
Gross urinary incontinence
Patient has undergone cystectomy
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There is 1 Location for this study
Rochester Minnesota, 55905, United States More Info
Principal Investigator
Principal Investigator
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