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
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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
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
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
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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
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...