Non-Invasive Diagnostics of Small Renal Masses

NCT03667885 | Unknown

• 1 other identifier: OP_125
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Renal Cell Carcinoma; Renal Tumor

Keywords

next generation sequencing; multi planar magnetic resonance; liquid biopsies; non-invasive diagnostics; biomarkers

Outcome Measures

Primary Outcomes (3)

• Expression of mRNA and DNA markers

  Expression levels of the sequences identified, in blood and urine will be compared by means of Whitney U test and Kruskal-Wallis test.

  Baseline

• Change in mRNA and DNA markers

  Changes in levels of expression from pre-operative to post-operative will be evaluated with Friedman´s ANOVA and subsequent post-hoc pairwise comparison with Wilcoxon's signed rank test with Bonferroni correction

  1 month, and 6 months

• Analysis of MpMRIs

  A specialist radiologist will examine the scans in a blinded fashion, meaning that he will be ignorant to the pathologist´s diagnosis.

  Baseline

Secondary Outcomes (1)

• Expression of mRNA and DNA markers

  Fourteen days after first samples

Study Arms (1)

Small renal Masses

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.

Diagnostic Test: Blood sample; Diagnostic Test: urine sample; Diagnostic Test: Multi planar MRI

Interventions

Blood sample DIAGNOSTIC_TEST

basic blood sample

Small renal Masses

urine sample DIAGNOSTIC_TEST

basic urine sample

Small renal Masses

Multi planar MRI DIAGNOSTIC_TEST

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

Small renal Masses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who presents with a small renal mass \<4cm.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense Universitets Hospital

Odense, Fyn, 5000, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, and tumor samples will be collected and analysed for an array of mRNAs and DNA biomarkers

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Blood Specimen Collection

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Anders U Frey, Ph.D student

  Odense UH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anders Ullmann U Frey, Ph.D student

CONTACT

26846961; freyen60@gmail.com

Lars Lund, Professor

CONTACT

51 40 89 82; lars.lund@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: September 12, 2018
• Study Start: March 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: September 1, 2020
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)