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Chromophobe Renal Cell CarcinomaNCT06339138

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 of Chromophobe Renal Cell Carcinoma and Clear Cell Papillary Renal Tumor, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Non-Interventional Study
How many people
589 participants
Where
1 siteUnited States
Study dates
27 Jun 2018to 12 Nov 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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
Show all 9Show fewer
  • HEALTHY CONTROL BLOODS AND URINE:
  • Patients has undergone negative hematuria workups (defined as negative abdominal imaging and negative cystoscopy
  • Age >= 18 years

Who cannot join

  • 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
Show all 43Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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

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:

  1. 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.

Being tested
Non-Interventional Study
Medical subject headings
Carcinoma, Renal Cell, Oncocytoma, renal, Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-Interventional StudyOther

    Non-interventional study

Study groups in NCT06339138
Study groupRoleWhat they receive
ObservationalParticipants may undergo blood, urine, and tissue sample collection on study. Participants' medical records are also reviewed.
Receives: Other: Non-Interventional Study

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%.

    Measured: Baseline (at enrollment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2024
  2. Study start27 Jun 2018
  3. Primary completion12 Nov 2025
  4. Study completion12 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
589 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06339138
Sponsor's protocol ID
17-010944
Status last verified
Jun 2026
First submitted
25 Mar 2024
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chromophobe Renal Cell Carcinoma and Clear Cell Papillary Renal Tumor, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identify novel methylated DNA markers in tissue for malignant renal and urothelial tumors (time frame: Baseline (at enrollment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06339138.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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