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Trial Title:
A Companion Diagnostic Study to Develop Circulating Exosomes as Predictive Biomarkers for the Response to Immunotherapy in Renal Cell Carcinoma
NCT ID:
NCT05705583
Condition:
Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Other: Blood and Urine Collection
Description:
Blood and Urine Collection
Summary:
Immune checkpoint inhibitors targeting PD-1 or PD-L1 have been developed and clinical
trials showning better response in unselected patients with metastatic renal cell
carcinoma (RCC). At the moment, no clear biomarker exists to accurately predict
anti-PD1/PDL1 RCC responsiveness. The objective of this study is to develop and evaluate
the utility of circulating exosomes as companion diagnostic biomarker for predicting
response to immunotherapy in patients with RCC.
Criteria for eligibility:
Study pop:
Adults with renal cell carcinoma
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Advanced Metastatic RCC
- Scheduled to initiate an immunocheckpoint inhibitors or in combination with them
- Age >= 18 years
- Able to provide informed consent
Exclusion Criteria:
- Other, unrelated, concomitant active, invasive malignancy
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
An Zhao
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
An Zhao, Dr
Phone:
+8618258863556
Email:
zhaoan@zjcc.org.cn
Investigator:
Last name:
An Zhao, PHD
Email:
Principal Investigator
Investigator:
Last name:
Zongping Wang, MD
Email:
Principal Investigator
Investigator:
Last name:
Yipeng Xu, MD
Email:
Principal Investigator
Start date:
January 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05705583
