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A Companion Diagnostic Study to Develop Circulating Exosomes as Predictive Biomarkers for the Response to Immunotherapy in Renal Cell Carcinoma

NCT ID: NCT05705583

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Other: Blood and Urine Collection

Blood and Urine Collection

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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ZHAO An

Zhejiang Cancer Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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An Zhao

Hangzhou, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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An Zhao, Dr

Role: primary

References

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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. 2023 Apr;66(4):875-878. doi: 10.1007/s11427-022-2197-7. Epub 2022 Dec 1. No abstract available.

Reference Type RESULT
PMID: 36469217 (View on PubMed)

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.

Reference Type RESULT
PMID: 35784363 (View on PubMed)

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.

Reference Type RESULT
PMID: 28753793 (View on PubMed)

Other Identifiers

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RCC-CDx-001

Identifier Type: -

Identifier Source: org_study_id