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NCT06339138Completed

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

Identification of Novel High Quality Methylated DNA Markers in Renal Tumors: Whole Methylome Discovery, Tissue Validation, and Feasibility Testing in Blood and Urine

Source: ClinicalTrials.gov · Last updated 1 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
589 (actual)
First submitted
25 Mar 2024
Start date
27 Jun 2018
Primary completion date
12 Nov 2025
Lead sponsor
Mayo Clinic
NCT number
NCT06339138

What you commit to

  • Study type: Observational
  • Participants enrolled: 589
  • From 27 Jun 2018 to the primary completion date, 12 Nov 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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
    • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mayo Clinic in Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.