Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548867
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib a GENomic Signature for Describing Long-lasting Response
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CABOGEN
Brief Summary:
CABOGEN is a Observational retrospective multicenter study that will enroll patients with metastatic clear cell renal carcinoma mccRCC treated with cabozantinib after one or more previous lines of treatment that included TKIs immune checkpoint inhibitors or mTOR inhibitors
Detailed Description:
The aim of this study is to describe the genomic profiling of patients with metastatic renal cell carcinoma mRCC who are long-lasting responders to treatment with cabozantinib and patients who are not long-lasting responders to the cabozantinib treatment
The study plan to enroll about 80 patients in 10 Italian centers
Group A 40 patients defined as long-lasting responders PFS 9 months Group B 40 patients defined as primary refractories to cabozantinib PFS 3 months
Tissue samples from nephrectomy or from a metastatic site will be used to perform genomic profiling not older than 5 yearsTissue should be formalin-fixed paraffin-embedded FFPE
Genomic profiling will be performed with a hybrid capture-based next-generation sequencing assay FoundationONE The sample will be assayed for all coding exons of 324 cancer-related genes plus select introns from 34 genes that are frequently rearranged in cancer Sequencing will be performed to a mean exon coverage depth of 500X The resulting sequences will be analyzed for all classes of genomic alteration including short variant alterations copy number alterations and selected gene fusions or rearrangements
The study plan to enroll about 80 patients in 10 Italian centers
Group A 40 patients defined as long-lasting responders PFS 9 months Group B 40 patients defined as primary refractories to cabozantinib PFS 3 months
Tissue samples from nephrectomy or from a metastatic site will be used to perform genomic profiling not older than 5 yearsTissue should be formalin-fixed paraffin-embedded FFPE
Genomic profiling will be performed with a hybrid capture-based next-generation sequencing assay FoundationONE The sample will be assayed for all coding exons of 324 cancer-related genes plus select introns from 34 genes that are frequently rearranged in cancer Sequencing will be performed to a mean exon coverage depth of 500X The resulting sequences will be analyzed for all classes of genomic alteration including short variant alterations copy number alterations and selected gene fusions or rearrangements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None