Clear Cell Renal Cell Carcinoma Clinical Trial
— ITHORinVHLOfficial title:
Overtaking Intra and Inter Tumoral Heterogeneity In Von Hippel-Lindau Related Renal Cancer
The goal of this study is to comprehensively map intra and inter tumor heterogeneity of ccRCC in VHL patients through the use of imaging, molecular biology and genomics techniques.
Status | Recruiting |
Enrollment | 3 |
Est. completion date | August 31, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - VHL syndrome - Presence of at least 3 kidney tumors larger that 3cm to be surgically removed Exclusion Criteria: - Absence of VHL - Quantity of kidney tumors < 3 - Absence of surgery performance |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Ospedale San Raffaele | Milan | MI |
Lead Sponsor | Collaborator |
---|---|
IRCCS San Raffaele |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Integrating Imaging and multiregion biopsy sampling in VHL related ccRCC | Pre-surgery imaging will be integrated using conventional multiparametric MRI with tumor histology of geographical predeterminated multi-region biopsies in each ccRCC of VHL patients. | From month 3 to month 20 | |
Primary | Determine immune and stromal heterogeneity in VHL-ccRCC | Multiplex immunohistochemistry, bulk and single cell RNA sequencing and somatic mutations analysis with pan-tumor histological assessment will be combined. | DNAseq and bulk RNAseq will be carried out from month 7 until month 20. Multiplex immunohistochemistry (IHC) in multiregional biopsies and standard IHC on the whole tumors will be performed the last 12 months of the study. | |
Primary | Generation and characterization of VHL-ccRCC patient-derived organoids | A protocol to generate VHL-ccRCC-derived tumor organoids (patient-derived organoids, PDO) will be optimized to test anti tumor agents like HIF2alpha inhibitor in organoid cultures representative of intra- and inter-tumor heterogeneity. | From month 3 until the end of the project. |
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