Biomarkers of Renal Cancer (BRC)

March 14, 2023 updated by: Biorek S.R.L.

The aim of the present study is the identification, in liquid biopsies, of a new molecular panel able to discriminate renal cancer patients from controls, to discriminate patients with a malignant lesion from those with a benign mass, to determine aggressiveness of RCC, and to differentiate the most common histological subtypes of RCC (clear cell, papillary 1, papillary 2, and chromophobe).

This new molecular panel will be combined with clinical parameters to provide a screening test and to improve the accuracy and specificity of diagnosis, prognosis, and histological classification of renal cancer.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The study is a translational one of the duration of 7 years and it is composed by a retrospective and a prospective phases.

  1. Retrospective phase:

    Retrospective analysis of liquid and solid biopsies of patients diagnosed with a first episode of renal mass (of any histological subtype, such as clear cell RCC, type 1 and type 2 papillary RCC, chromophobe RCC, oncocytoma, and angiomyolipoma) and treated with radical or partial nephrectomy, in order to identify specific biomarkers for the screening, diagnosis, prognosis, and histological classification of renal cancer.

    Patients with a first episode of renal mass whose plasma, urine, tumor and matched normal kidney tissue, and PBMC have been collected and stored in a biobank since 2011, will be stratified in different groups according to (i) the nature of renal mass (benign or malignant), (ii) the aggressiveness of renal cancer (indolent kidney cancer or aggressive kidney cancer), and (iii) the presence or absence of clinical metastasis; (iv) specific histotype of renal mass (e.g., clear cell RCC, type 1 and type 2 papillary RCC, chromophobe RCC, oncocytoma, and angiomyolipoma).

    The same type of biological samples mentioned above from patients affected by urological functional diseases (such as kidney stones or benign prostate hypertrophy) have been collected and stored in a biobank between 2014 and 2018 and will be also analyzed as controls.

    The samples will be fractionated and subjected to different analysis, such as the detection of nucleic acids (DNA and RNA), and proteins. These macromolecules will be purified and analyzed by employing methods such as real time PCR, microarrays, sequencing, ELISA assays, or mass spectrometry.

  2. Prospective phase and multicenter trial:

Validation of the biomarker panel in a wider cohort of patients affected by renal mass.

An ideal tumor marker is easily detected and dosed, is sensitive and specific and its clinical significance is easy to deduce. To confirm the results obtained in archived samples and validate a panel of biomarkers to be translate in the clinical practice, it will be collected whole blood, plasma and urine samples from a validation cohort of patients.

It will enrolled patients affected by renal masses (e.g., clear cell RCC, type 1 and type 2 papillary RCC, chromophobe RCC, oncocytoma, and angiomyolipoma), who will undergo radical or partial nephrectomy, and controls (patients affected by urological functional diseases, such as kidney stones or benign prostate hypertrophy) with a ratio of 2:1 in all centers included.

For each patients, clinical data will be collected, creating a dataset with the same variables used in the discovery cohort.

The aim of this prospective phase will be to confirm that the identified molecules can improve the management of patients with RCC at all the stages of clinical decision-making, in particular for the screening, diagnosis, prognosis, and histological classification of RCC.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Firenze, Italy, 50139
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi
        • Contact:
          • Andrea Mari
      • Milano, Italy, 20132
        • Recruiting
        • IRCCS San Raffaele
        • Contact:
          • Francesco Montorsi
      • Orbassano, Italy, 10043
        • Recruiting
        • Azienda Ospedaliera Universitaria San Luigi Gonzaga
        • Contact:
          • Daniele Amparore
  • Spain
      • Barcelona, Spain, 08025
        • Recruiting
        • Fundacio Puigvert
        • Contact:
          • Angelo Territo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cases: patients diagnosed with a first episode of renal mass. Control subjects: living kidney donor or patient with urological functional diseases.

Description

Inclusion Criteria for renal-mass patients:

  • Men and women over 18 years of age
  • Diagnosis of first episode of renal mass
  • Caucasian race
  • Signed, informed consent

Exclusion Criteria renal-mass patients:

  • Any other concomitant cancer or history of active cancer in the last 5 years
  • Oncological genetic syndrome
  • Previous history of renal tumour
  • Urothelial cancer
  • End-stage renal disease on hemodialysis
  • Bilateral renal cell carcinoma

Inclusion Criteria for control subjects:

  • Men and women over 18 years of age
  • Caucasian race
  • Living kidney donor or patient with urological functional diseases (e.g. kidney stones, benign prostate hypertrophy, etc..)
  • Signed, informed consent

Exclusion criteria for control subjects:

  • History of active cancer in the last 5 years
  • Oncological genetic syndrome
  • End-stage renal disease on hemodialysis or peritoneal dialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Renal-mass patients
Patients diagnosed with a first episode of renal mass attending the urology department.
Control subjects
Patients affected by urological functional diseases or living kidney donor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screening
Time Frame: Analysis of biological samples collected before surgery
Identification of biomarkers able to predict the presence of a renal mass, defined as a mass either benign or malignant recorded at axial imaging examination (either CT or MRI).
Analysis of biological samples collected before surgery
Diagnosis
Time Frame: Analysis of biological samples collected before surgery
Identification of biomarkers able to predict the presence of a Renal Cell Carcinoma, defined as a renal malignancy
Analysis of biological samples collected before surgery
Prognosis
Time Frame: Analysis of biological samples collected before surgery
Identification of biomarkers able to predict the presence of an aggressive Renal Cell Carcinoma
Analysis of biological samples collected before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biorek S.R.L.

Investigators

  • Principal Investigator: Francesco Montorsi, IRCCS San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2019

Primary Completion (Anticipated)

June 1, 2026

Study Completion (Anticipated)

June 1, 2026

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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