NCT06339138

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
589

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jun 2018Jan 2027

Study Start

First participant enrolled

June 27, 2018

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

8.6 years

First QC Date

March 25, 2024

Last Update Submit

December 18, 2025

Conditions

Chromophobe Renal Cell CarcinomaClear Cell Papillary Renal TumorClear Cell Renal Cell CarcinomaUrothelial CarcinomaKidney OncocytomaPapillary Renal Cell Carcinoma

Outcome Measures

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%.

    Baseline (at enrollment)

Study Arms (1)

Observational

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

Other: Non-Interventional Study

Interventions

Non-Interventional StudyOTHER

Non-interventional study

Observational

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +28 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Samples retained with permission of participant.

MeSH Terms

Conditions

Carcinoma, Renal CellOncocytoma, renalCarcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • John B. Kisiel, MD

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 1, 2024

Study Start

June 27, 2018

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

December 24, 2025

Record last verified: 2025-12

Locations

US(1)