Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05785052
Status:
RECRUITING
Last Update Posted:
2023-03-27
First Post:
2023-03-14
Brief Title:
Biomarkers of Renal Cancer
Sponsor:
Biorek SRL
Organization:
Biorek SRL
Study Overview
Official Title:
Biomarkers of Renal Cancer
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRC
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
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 eg 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 eg 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 21 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
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 eg 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 eg 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 21 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None