Actively Recruiting

Age: 18Years +
All Genders
ID05785052

Biomarkers of Renal Cancer to Improve Screening, Diagnosis, and Prognosis through Liquid Biopsies

Led by Biorek S.R.L. · Updated on 2023-03-27

1000

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying renal cancer to identify a new molecular panel from liquid biopsies. This panel aims to distinguish renal cancer patients from healthy controls, differentiate malignant from benign kidney masses, assess the aggressiveness of renal cell carcinoma (RCC), and classify common RCC subtypes such as clear cell, papillary types 1 and 2, and chromophobe. The study combines molecular data with clinical information to improve screening, diagnosis, prognosis, and histological classification of renal cancer. The study includes two phases: a retrospective phase analyzing stored samples from patients with a first episode of renal mass and controls with urological functional diseases, and a prospective phase involving a multicenter trial. During the retrospective phase, various biological samples like plasma, urine, tumor tissue, and normal kidney tissue are analyzed using methods such as PCR, sequencing, and mass spectrometry. The prospective phase collects fresh whole blood, plasma, and urine samples from patients undergoing nephrectomy and controls, aiming to validate the biomarker panel in a larger group. Participants will provide biological samples before surgery, along with clinical data to build a comprehensive dataset. Researchers will analyze these samples to measure biomarkers related to screening, diagnosis, and prognosis of RCC. The study involves ongoing sample collection and data analysis to confirm the clinical usefulness of the biomarker panel for managing renal cancer. Participation includes providing informed consent and attending scheduled visits during the study period, which runs through June 2026.

CONDITIONS

Brief Title

Biomarkers of Renal Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women over 18 years of age
  • Diagnosis of first episode of renal mass
  • Caucasian race
  • Signed, informed consent
  • Living kidney donor or patient with urological functional diseases (e.g., kidney stones, benign prostate hypertrophy) for control subjects
Not Eligible

You will not qualify if you...

  • 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 or peritoneal dialysis
  • Bilateral renal cell carcinoma

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to time of surgery

Participants provide biological samples such as whole blood, plasma, and urine before surgery to identify and validate biomarkers for renal cancer screening, diagnosis, and prognosis.

1 to 2 visits depending on sample collection timing

Long-term Monitoring

Duration - Up to 7 years

Participants are observed through clinical data collection and analysis to evaluate the biomarker panel's effectiveness in managing renal cancer.

Visits as part of routine clinical care; specific visit schedule varies

Trial Site Locations

Total: 4 locations

1

Azienda Ospedaliera Universitaria Careggi

Florence, Italy, 50139

Actively Recruiting

2

IRCCS San Raffaele

Milan, Italy, 20132

Actively Recruiting

3

Azienda Ospedaliera Universitaria San Luigi Gonzaga

Orbassano, Italy, 10043

Actively Recruiting

4

Fundació Puigvert

Barcelona, Spain, 08025

Actively Recruiting

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Research Team

F

Francesco Trevisani

A

Alessandra Cinque

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Nephron-sparing techniques independently decrease the risk of cardiovascular events relative to radical nephrectomy in patients with a T1a-T1b renal mass and normal preoperative renal function.

Umberto Capitanio, Carlo Terrone, Alessandro Antonelli...

https://pubmed.ncbi.nlm.nih.gov/25282367

Large-scale genome-wide screening of circulating microRNAs in clear cell renal cell carcinoma reveals specific signatures in late-stage disease.

Estelle Chanudet, Magdalena B Wozniak, Liacine Bouaoun...

https://pubmed.ncbi.nlm.nih.gov/28639257

The Role of Tobacco Smoke in Bladder and Kidney Carcinogenesis: A Comparison of Exposures and Meta-analysis of Incidence and Mortality Risks.

Marcus G Cumberbatch, Matteo Rota, James W F Catto...

https://pubmed.ncbi.nlm.nih.gov/26149669

Analysis of serum microRNAs (miR-26a-2*, miR-191, miR-337-3p and miR-378) as potential biomarkers in renal cell carcinoma.

Stefan Hauser, Lena M Wulfken, Stefan Holdenrieder...

https://pubmed.ncbi.nlm.nih.gov/22542158

Five-year survival after surgical treatment for kidney cancer: a population-based competing risk analysis.

John M Hollingsworth, David C Miller, Stephanie Daignault...

https://pubmed.ncbi.nlm.nih.gov/17351954