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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05705583

Enrollment

100

Registered

2023-01-31

Start date

2023-01-01

Completion date

2025-12-31

Last updated

2023-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Carcinoma

Brief 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.

Interventions

OTHEROther: Blood and Urine Collection

Blood and Urine Collection

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The correlation between the circulating exosomes levels and the tumor responsiveness	3 years	The Measurement： The concentration of ciruculating exosomes and the expression level of exosomal RNA. The Measurement Tool: RT-PCR，WB and Elisa

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026