A Study to Identify Novel High Quality Methylated DNA Markers in Renal Tumors

Overview

About this study

Primary Aims

  1. In tissue, to discover and validate DNA methylation markers (MDMs) for detection of malignant renal and urothelial tumors.
  2. In blood, to assess the accuracy of candidate MDMs from above for detection of malignant renal and urothelial tumors.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

INCLUSION CRITERIA - Case Tissue:

  • Patient has a histological diagnosis of primary clear cell RCC, papillary cell RCC, chromophobe RCC, oncocytoma, or urothelial cell carcinoma.
  • Age > 18 years old.

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-Dubé 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 drugsin 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 Neuphritis (Glomerulus or Interstitial), Poly Cystic Kidney Disease, Glomerulonephropathies or Acquired Renal Kidney Disease.

EXCLUSION CRITERIA - 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-Dubé 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 Neuphritis (Glomerulus or Interstitial), Poly Cystic Kidney Disease, Glomerulonephropathies or Acquired Renal Kidney Disease.

EXCLUSION CRITERIA - Urothelial 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.

INCLUSION CRITERIA - 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 old.

EXCLUSION CRITERIA - Case 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-Dubé syndrome (BHD).
  • Gross urinary incontinence.
  • Patient has undergone cystectomy.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

John Cheville, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Grant Dubbels

(507)538-6151

Dubbels.Grant@mayo.edu

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions