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

NCT05705583 | Unknown

• 1 other identifier: RCC-CDx-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

  3 years

Interventions

Other: Blood and Urine Collection OTHER

Blood and Urine Collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with renal cell carcinoma

You may qualify if:

• Advanced Metastatic RCC
• Scheduled to initiate an immunocheckpoint inhibitors or in combination with them
• Age \>= 18 years
• Able to provide informed consent

You may not qualify if:

• Other, unrelated, concomitant active, invasive malignancy

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

An Zhao

Hangzhou, 310022, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 36469217 RESULT

• 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.

  PMID: 35784363 RESULT

• 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.

  PMID: 28753793 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Collection of blood and urine specimens from patients receiving immunotherapy as part of their standard of care for the treatment of RCC

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Urine Specimen Collection

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zhejiang Cancer Hospital

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 31, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)