Renal Cell Carcinoma Clinical Trial
Official title:
A Companion Diagnostic Study to Develop Circulating Exosomes as Predictive Biomarkers for the Response to Immunotherapy in Renal Cell Carcinoma
| Verified date | January 2023 |
| Source | Zhejiang Cancer Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 31, 2025 |
| Est. primary completion date | December 31, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| China | An Zhao | Hangzhou |
| Lead Sponsor | Collaborator |
|---|---|
| Zhejiang Cancer Hospital |
China,
Wang H, Zhu Z, Zhang Y, Jiang T, Zhang M, Wang Z, Zhang Y, Zhao A, Su B. New insight into immune checkpoint inhibitors in the treatment of advanced renal cell carcinoma. Sci China Life Sci. 2022 Dec 1. doi: 10.1007/s11427-022-2197-7. Online ahead of print — View Citation
Yu M, Liu X, Xu H, Shen S, Wang F, Chen D, Li G, Wang Z, Zuo Z, Zhao A. Comprehensive Evaluation of the m6A Regulator Prognostic Risk Score in the Prediction of Immunotherapy Response in Clear Cell Renal Cell Carcinoma. Front Immunol. 2022 Jun 17;13:81812 — View Citation
Zhang W, Ni M, Su Y, Wang H, Zhu S, Zhao A, Li G. MicroRNAs in Serum Exosomes as Potential Biomarkers in Clear-cell Renal Cell Carcinoma. Eur Urol Focus. 2018 Apr;4(3):412-419. doi: 10.1016/j.euf.2016.09.007. Epub 2016 Oct 14. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The correlation between the circulating exosomes levels and the tumor responsiveness | The Measurement: The concentration of ciruculating exosomes and the expression level of exosomal RNA.
The Measurement Tool: RT-PCR,WB and Elisa |
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