Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06195150
Other study ID # PNRR-MR1-2022-12375818
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 8, 2023
Est. completion date August 31, 2024

Study information

Verified date March 2024
Source IRCCS San Raffaele
Contact Umberto Capitanio, MD
Phone 3492503788
Email capitanio.umberto@hsr.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.


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: 1. To integrate pre-surgery imaging using conventional multiparametric MRI with tumor histology of geographical predeterminated multi-region biopsies in each ccRCC of VHL patients. 2. To combine multiplex immunohistochemistry, bulk and single cell RNA sequencing and somatic mutations analysis with pan-tumor histological assessment. 3. 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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
Blood collection
15ml of blood are harvested before surgery

Locations

Country Name City State
Italy IRCCS Ospedale San Raffaele Milan MI

Sponsors (1)

Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

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.
See also
  Status Clinical Trial Phase
Completed NCT03163667 - CB-839 With Everolimus vs. Placebo With Everolimus in Participants With Renal Cell Carcinoma (RCC) Phase 2
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Withdrawn NCT02307474 - A Pilot Study of SBRT With Adjuvant Pazopanib for Renal Cell Cancer N/A
Completed NCT00101114 - Sorafenib and Interferon Alfa in Treating Patients With Metastatic or Unresectable Kidney Cancer Phase 2
Completed NCT00078858 - Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant Phase 1/Phase 2
Recruiting NCT05363631 - Seleno-L Methionine (SLM)-Axitinib-Pembrolizumab Phase 1/Phase 2
Terminated NCT01198158 - Everolimus With or Without Bevacizumab in Treating Patients With Advanced Kidney Cancer That Progressed After First-Line Therapy Phase 3
Completed NCT00378703 - Bevacizumab, Sorafenib Tosylate, and Temsirolimus in Treating Patients With Metastatic Kidney Cancer Phase 2
Recruiting NCT06138496 - Cadonilimab Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC Phase 2
Recruiting NCT06088134 - Contrast-enhanced CT-based Deep Learning Model for Preoperative Prediction of Disease-free Survival (DFS) in Localized Clear Cell Renal Cell Carcinoma (ccRCC)
Recruiting NCT06049576 - Nivolumab and Ipilimumab With and Without Camu Camu for the Treatment of Patients With Metastatic Renal Cell Carcinoma Phase 1
Active, not recruiting NCT01038778 - Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer Phase 1/Phase 2
Recruiting NCT05536141 - A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors Phase 1
Recruiting NCT05119335 - A Study of NKT2152, a HIF2α Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma Phase 1/Phase 2
Completed NCT01243359 - Sunitinib Malate and Bevacizumab in Treating Patients With Kidney Cancer or Advanced Solid Malignancies Phase 1
Terminated NCT00098618 - Sorafenib and Interferon Alfa in Treating Patients With Locally Advanced or Metastatic Kidney Cancer Phase 2
Recruiting NCT05620134 - Study of JK08 in Patients With Unresectable Locally Advanced or Metastatic Cancer Phase 1/Phase 2
Recruiting NCT06052852 - Study of BDC-3042 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Malignancies Phase 1/Phase 2
Completed NCT03680521 - Neoadjuvant Sitravatinib in Combination With Nivolumab in Patients With Clear Cell Renal Cell Carcinoma Phase 2
Active, not recruiting NCT02293980 - A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma (MK-3795-001) Phase 1