- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05705583
A Companion Diagnostic Study to Develop Circulating Exosomes as Predictive Biomarkers for the Response to Immunotherapy in Renal Cell Carcinoma
January 30, 2023 updated by: ZHAO An, Zhejiang Cancer Hospital
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hangzhou, China, 310022
- Recruiting
- An Zhao
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Contact:
- An Zhao, Dr
- Phone Number: +8618258863556
- Email: zhaoan@zjcc.org.cn
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Principal Investigator:
- An Zhao, PHD
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Principal Investigator:
- Zongping Wang, MD
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Principal Investigator:
- Yipeng Xu, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adults with renal cell carcinoma
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The correlation between the circulating exosomes levels and the tumor responsiveness
Time Frame: 3 years
|
The Measurement: The concentration of ciruculating exosomes and the expression level of exosomal RNA. The Measurement Tool: RT-PCR,WB and Elisa |
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. No abstract available.
- 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;13:818120. doi: 10.3389/fimmu.2022.818120. eCollection 2022.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Anticipated)
December 31, 2025
Study Completion (Anticipated)
December 31, 2025
Study Registration Dates
First Submitted
January 12, 2023
First Submitted That Met QC Criteria
January 30, 2023
First Posted (Actual)
January 31, 2023
Study Record Updates
Last Update Posted (Actual)
January 31, 2023
Last Update Submitted That Met QC Criteria
January 30, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCC-CDx-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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