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

NCT06339138 | Completed

• 1 other identifier: 17-010944
• Study Type: observational
• Target: 589
• Locations: 1 country
• Sites: 1

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.

Conditions

Chromophobe Renal Cell Carcinoma; Clear Cell Papillary Renal Tumor; Clear Cell Renal Cell Carcinoma; Urothelial Carcinoma; Kidney Oncocytoma; Papillary 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 Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Samples retained with permission of participant.

MeSH Terms

Conditions

Carcinoma, Renal Cell; Oncocytoma, renal; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male 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: November 12, 2025
• Study Completion: November 12, 2025
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

US (1)