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CompletedNCT06339138Updated Jul 1, 2026

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

An observational study in Chromophobe Renal Cell Carcinoma, Clear Cell Papillary Renal Tumor and Clear Cell Renal Cell Carcinoma, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
589
Ages
18 Years and older
Sex
All
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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.

Read the detailed 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.

02

Conditions studied

  • Chromophobe Renal Cell Carcinoma
  • Clear Cell Papillary Renal Tumor
  • Clear Cell Renal Cell Carcinoma
  • Kidney Oncocytoma
  • Papillary Renal Cell Carcinoma
  • Urothelial Carcinoma
03

In context

Carcinoma, Renal Cell

1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.

This study's enrollment of 589 is above the median of 146 across 360 observational studies indexed under Carcinoma, Renal Cell.

Browse Carcinoma, Renal Cell studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with a histological diagnosis of primary clear cell RCC, papillary cell RCC, clear cell papillary RCC, chromophobe RCC, oncocytoma, urothelial cell carcinoma, or healthy participants who have undergone negative hematuria workups

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

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
  • 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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
589 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Observational

    Participants may undergo blood, urine, and tissue sample collection on study. Participants' medical records are also reviewed.

    Other: Non-Interventional Study

Interventions

  • OtherNon-Interventional Study

    Non-interventional study

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What researchers measure

Primary outcomes

  1. Identify novel methylated DNA markers in tissue for malignant renal and urothelial tumors

    Assessed by the number of markers identified using unbiased whole methylome sequencing (RRBS). Top candidates will be validated in independent tissue. Potential markers will have relatively low background and a false discovery rate 20%.

    Time frame: Baseline (at enrollment)

07

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06339138
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Apr 1, 2024
Start date
Jun 27, 2018
Primary completion
Nov 12, 2025
Completion
Nov 12, 2025
Last update
Jul 1, 2026

Study contacts

John B. Kisiel, MD
principal investigator · Mayo Clinic in Rochester

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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