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Non-Invasive Diagnostics of Small Renal Masses

NCT03667885 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2019-03-19

No results posted yet for this study

Summary

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

Interventions

DIAGNOSTIC_TEST

Blood sample

basic blood sample

DIAGNOSTIC_TEST

urine sample

basic urine sample

DIAGNOSTIC_TEST

Multi planar MRI

T1 (with reduced affinity for fatty tissue) +/- contrast, diffusion weighted sequences and wash in/wash out

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Anders U Frey, Ph.D student · Odense UH

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2020-01-31
Completion
2020-09-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03667885 on ClinicalTrials.gov