Trial Title:
Biomarkers of Renal Cancer
NCT ID:
NCT05785052
Condition:
Renal Cell Carcinoma
Tumor, Solid
Oncocytoma
Angiomyolipoma
Conditions: Official terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Angiomyolipoma
Adenoma, Oxyphilic
Conditions: Keywords:
Biomarkers
Urology
Renal Cell Carcinoma
Molecular Biomarkers
Oncology
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Cases: patients diagnosed with a first episode of renal mass. Control subjects: living
kidney donor or patient with urological functional diseases.
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Azienda Ospedaliera Universitaria Careggi
Address:
City:
Firenze
Zip:
50139
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Andrea Mari
Facility:
Name:
IRCCS San Raffaele
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Francesco Montorsi
Facility:
Name:
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Address:
City:
Orbassano
Zip:
10043
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Daniele Amparore
Facility:
Name:
Fundació Puigvert
Address:
City:
Barcelona
Zip:
08025
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Angelo Territo
Start date:
June 11, 2019
Completion date:
June 2026
Lead sponsor:
Agency:
Biorek S.R.L.
Agency class:
Industry
Source:
Biorek S.R.L.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05785052
