Clear Cell Renal Cell CarcinomaITHORinVHLNCT06195150
Overtaking Intra and Inter Tumoral Heterogeneity In Von Hippel-Lindau Related Renal Cancer
An observational study of Clear Cell Renal Cell Carcinoma and VHL Syndrome, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma, VHL Syndrome
- What is being tested?
- Blood collection
- How many people
- 3 participants
- Where
- 1 siteItaly
- Study dates
- 8 Nov 2023to 19 May 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: VHL patients with at least 3 kidney tumors larger that 3cm to be surgically removed
Who may be able to join
- VHL syndrome
- Presence of at least 3 kidney tumors larger that 3cm to be surgically removed
Who cannot join
- Absence of VHL
- Quantity of kidney tumors < 3
- Absence of surgery performance
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
It was hypothesized that the high intra- inter-tumor heterogeneity of sporadic ccRCC also defines VHL-ccRCCs, including different lesions within individual patients, and it was assumed that decoding VHL-ccRCC heterogeneity by coupling imaging, histology and molecular profiling of multiregional biopsies would help improve diagnostic tests and therapeutic choices for VHL patients.
In order to comprehensively map intra and inter tumor heterogeneity of ccRCC in VHL patients, the aims of the study are:
- To integrate pre-surgery imaging using conventional multiparametric MRI with tumor histology of geographical predeterminated multi-region biopsies in each ccRCC of VHL patients.
- To combine multiplex immunohistochemistry, bulk and single cell RNA sequencing and somatic mutations analysis with pan-tumor histological assessment.
- To optimize a protocol to generate VHL-ccRCC-derived tumor organoids (patient-derived organoids, PDO) and test anti tumor agents like HIF2alpha inhibitor in organoid cultures representative of intra- and inter-tumor heterogeneity.
This study will develop standardized models for diagnosis and molecular characterization of ccRCC in VHL disease using a combination of imaging, intrasurgical biopsying and multi-omics analysis. It will benefit of a clinical and research program devoted to VHL disease established at OSR in 2021 that centralizes Italian VHL patients. Since the current study relies on tumor biopsy techniques that are already established in clinical practice, the translational findings will be directly available and immediately affecting patients' care.
- Conditions
- Clear Cell Renal Cell Carcinoma, VHL Syndrome
- Being tested
- Blood collection
- Medical subject headings
- Carcinoma, Renal Cell, von Hippel-Lindau Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionOther
15ml of blood are harvested before surgery
| Study group | Role | What they receive |
|---|---|---|
| VHL patients | Patients with hereditary Von Hippel-Lindau (VHL) with genetic diagnosis of VHL disease who have at least three tumors larger than 3cm that have to be surgically removed. The procedure involves standard surgery with the additional collection of 15ml of blood. Receives: Other: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From month 3 to month 20
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.
Measured: 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.
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.
Measured: From month 3 until the end of the project.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start8 Nov 2023
- Primary completion18 Jun 2025
- Study completion19 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umberto Capitanio, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195150
- Sponsor's protocol ID
- PNRR-MR1-2022-12375818
- Acronym
- ITHORinVHL
- Status last verified
- Oct 2026
- First submitted
- 22 Dec 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No