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

Urothelial Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06339138
• Other study ID #: 17-010944
• Secondary ID: NCI-2024-0097117
• Status: Recruiting
• Start date: February 20, 2018
• Est. completion date: January 31, 2027

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 874
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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

• UROTHELIEAL 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Chromophobe Renal Cell Carcinoma
• Clear Cell Renal Cell Carcinoma
• Kidney Neoplasms
• Kidney Oncocytoma
• Papillary Renal Cell Carcinoma
• Urothelial Carcinoma

Intervention

Other:
• Non-Interventional Study
Non-interventional study

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)