Clinical trial · Observational
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
Identification of Novel High Quality Methylated DNA Markers in Renal Tumors: Whole Methylome Discovery, Tissue Validation, and Feasibility Testing in Blood and Urine
NCT06339138CI-TRIAL-00116547completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chromophobe Renal Cell Carcinoma | Chromophobe Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Clear Cell Papillary Renal Tumor | Clear Cell Papillary Renal Tumor | ONTOLOGY_EXACT | 0.98 |
| Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Kidney Oncocytoma | Kidney Oncocytoma | ONTOLOGY_EXACT | 0.98 |
| Papillary Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational
- description
- Participants may undergo blood, urine, and tissue sample collection on study. Participants' medical records are also reviewed.
- interventionNames
- Other: Non-Interventional Study
Primary outcomes (1)
- measure
- Identify novel methylated DNA markers in tissue for malignant renal and urothelial tumors
- timeFrame
- Baseline (at enrollment)
- description
- 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%.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.