Identifying biomarkers for renal cancer diagnosis and classification
Biomarkers of Renal Cancer
Biorek S.R.L. · NCT05785052
This study is trying to find new markers in blood samples that can help doctors tell if someone has kidney cancer, how serious it is, and what type it is compared to healthy people and those with other kidney issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biorek S.R.L. (industry) |
| Locations | 4 sites (Florence and 3 other locations) |
| Trial ID | NCT05785052 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify a new molecular panel in liquid biopsies that can distinguish renal cancer patients from healthy controls, differentiate malignant lesions from benign masses, assess the aggressiveness of renal cell carcinoma (RCC), and classify the most common histological subtypes of RCC. The study includes both retrospective and prospective phases, analyzing stored biological samples from patients diagnosed with renal masses and comparing them to samples from individuals with urological functional diseases. The goal is to enhance the accuracy and specificity of renal cancer diagnosis, prognosis, and histological classification through the integration of these biomarkers with clinical parameters.
Who should consider this trial
Good fit: Ideal candidates include men and women over 18 years of age with a first episode of renal mass and of Caucasian race.
Not a fit: Patients with a history of active cancer in the last 5 years or those with end-stage renal disease on dialysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and earlier diagnosis of renal cancer, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using biomarkers for cancer diagnosis, but this specific approach is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Florence and 3 other locations
- Azienda Ospedaliera Universitaria Careggi — Florence, Italy (RECRUITING)
- IRCCS San Raffaele — Milan, Italy (RECRUITING)
- Azienda Ospedaliera Universitaria San Luigi Gonzaga — Orbassano, Italy (RECRUITING)
- Fundació Puigvert — Barcelona, Spain (RECRUITING)
Study contacts
- Principal investigator: Francesco Montorsi — IRCCS San Raffaele
- Study coordinator: Francesco Trevisani
- Email: francesco.trevisani@biorek.eu
- Phone: 0226435857
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Renal Cell Carcinoma, Tumor, Solid, Oncocytoma, Angiomyolipoma, Biomarkers, Urology, Molecular Biomarkers, Oncology