Clinical trial NCT05785052: Biomarkers of Renal Cancer
Official title: Biomarkers of Renal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Cell Carcinoma
Tumor, Solid
Oncocytoma
Angiomyolipoma
Keywords: Biomarkers
Urology
Renal Cell Carcinoma
Molecular Biomarkers
Oncology
Lead sponsor: Biorek S.R.L.
Sponsor class: INDUSTRY
First posted: 2023-03-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: Screening
timeFrame: Analysis of biological samples collected before surgery
measure: Diagnosis
timeFrame: Analysis of biological samples collected before surgery
measure: Prognosis
timeFrame: Analysis of biological samples collected before surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Milano
country: Italy
facility: IRCCS San Raffaele
city: Orbassano
country: Italy
facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga
city: Barcelona
country: Spain
facility: Fundació Puigvert
Study officials:
affiliation: IRCCS San Raffaele
name: Francesco Montorsi
role: PRINCIPAL_INVESTIGATOR
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