Clinical trial · Observational
Non-Invasive Diagnostics of Small Renal Masses
- 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)
NiSAR is a Ph.D. study and consists of three substudies. Renal cancer is one of the most deadly urologic malignancies and accounts for 900 new cases and 300 deaths per year. An increase in the use of imaging diagnostics has yielded a rise in the incidental detection of small renal masses (SRM), meaning tumors \<4cm (T1a). Kidney biopsies are the gold standard for diagnosing SRM but has an inherent risk of infections, retroperitoneal bleeding and in rare cases loss of kidney function. This is problematic since up to 30% of SRM are benign. This Ph.D. consists of three studies that all aim to develop new minimally invasive modalities for diagnosing SRM. Patients eligible for these studies are diagnosed with SRM at one of the departments of Urology in the southern region of Denmark. Studies 1 and 2 aims to find circulating biomarkers, in the form of DNA and messenger ribonucleic acid (mRNA) contained in micro vesicles secreted into blood by renal cell cancers and find changes in biomarkers levels after surgery. Study 3 aim to determine the potential of multiplanar MRI (mpMRI) to discriminate between benign and malign SRM. Potentially this can lead to a fundamental change of the way urologists diagnose and monitor SRM and renal cell cancer in general. The investigators will also build a research biobank for future research.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Renal Tumor | Kidney Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Diagnostic Test | — | UNRESOLVED |
| Multi planar MRI | Diagnostic Test | — | UNRESOLVED |
| urine sample | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Small renal Masses
- description
- patients with a renal mass of 4 cm or less. Typically incidentally found. Blood and urine samples will be collected from each patient at baseline before a biopsy of the tumor is collected and 14 days later. In addition, all patients will be offered a Multi planar MRI before the biopsy. Patients elected for curative treatment for malignant tumors will have another set of blood and urine samples collected at 1 month and 6 months after the intervention.
- interventionNames
- Diagnostic Test: Blood sample
- Diagnostic Test: urine sample
- Diagnostic Test: Multi planar MRI
Primary outcomes (3)
- measure
- Expression of mRNA and DNA markers
- timeFrame
- Baseline
- description
- Expression levels of the sequences identified, in blood and urine will be compared by means of Whitney U test and Kruskal-Wallis test.
- measure
- Change in mRNA and DNA markers
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients with SRM \< 4cm (T1a) at the Departments of Urology in the region of Southern Denmark. * Written consent * Able to speak and understand Danish Exclusion Criteria: * Patients below 18 years of age, * Patients with mental impairment * Withdrawal of consent * Other malignancies. Specific for study 2: * Patients unsuitable for curative treatment. Specific for study 3: * Pregnancy * Kidney failure * Kidney-grafts * History of allergic-reactions to contrast agents * Patients with non-MRI-compatible components * Patients unable to cooperate for an MRI.
References
Publications (0)
Data not yet available