Application Circulating Tumor DNA Dynamic Monitoring in Clinical Treatment of Metastatic Renal Cell Carcinoma
A Prospective Observational Study of Molecular Classification and Circulating Tumor DNA Dynamic Monitoring to Explore Related Factors That Predict the Efficacy of Single Targeted Therapy or Combined With Immunotherapy for Metastatic Renal Cell Carcinoma
1 other identifier
interventional
500
1 country
1
Brief Summary
Next-Generation Sequencing and whole transcriptome RNA sequencing were used to detect genomic variation and expression in tissues or blood, respectively. The treatment outcome of single targeted therapy or combined with immunotherapy was observed and followed up. Through this study, we intend to achieve RNA molecular classification of Chinese mRCC patients and to evaluate the correlation between ctDNA level, RNA molecular classification and treatment outcome, provide reference for metastatic RCC precise diagnosis and treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2022
CompletedFirst Submitted
Initial submission to the registry
October 22, 2022
CompletedFirst Posted
Study publicly available on registry
April 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedApril 18, 2023
April 1, 2023
1.4 years
October 22, 2022
April 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
progression-free survival
From drug taken until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months
Secondary Outcomes (1)
Objective Response Rate
From drug taken until the date of first documented progression, assessed up to 20 months
Study Arms (2)
Single targeted therapy
ACTIVE COMPARATORsunitinib or pazopanib
targeted therapy combined with immunotherapy
EXPERIMENTALProgrammed death-ligand 1 Inhibitor combined with axitinib
Interventions
targeted therapy combined with immunotherapy
Eligibility Criteria
You may qualify if:
- Clinically diagnosed with renal cell carcinoma confirmed by pathology, including clear renal cell carcinoma and type I papillary renal cell carcinoma, type II papillary renal cell carcinoma, chromophobe renal cell carcinoma and renal cell carcinoma with sarcomatoid differentiation, etc
- Have distant metastasis
- metastatic RCC
- Eastern Cooperative Oncology Group 0 to 1
- No obvious abnormality was found in blood routine examination, coagulation and liver and kidney function
You may not qualify if:
- Previously received systematic treatment
- Failure to obtain baseline tumor tissue / blood samples
- A history of infection with human immunodeficiency virus, or suffer from other acquired and congenital immunodeficiency diseases, or have a history of organ transplantation, or have a history of organ transplantation
- A history of allergy to disease treatment drugs
- During lactation or pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
- Ruijin Hospitalcollaborator
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicinecollaborator
- West China Hospitalcollaborator
- Xiangya Hospital of Central South Universitycollaborator
- Fudan Universitycollaborator
- Second Affiliated Hospital, School of Medicine, Zhejiang Universitycollaborator
- Second Affiliated Hospital of Nantong Universitycollaborator
- Peking University First Hospitalcollaborator
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong Universitycollaborator
- Shanghai Jiao Tong University Affiliated Sixth People's Hospitalcollaborator
- Zhejiang Universitycollaborator
- First Affiliated Hospital of Wenzhou Medical Universitycollaborator
- Sir Run Run Shaw Hospitalcollaborator
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical Schoolcollaborator
- The General Hospital of Eastern Theater Commandcollaborator
- The First Affiliated Hospital with Nanjing Medical Universitycollaborator
- The First Affiliated Hospital of University of Science and Technology of Chinacollaborator
- The Second Hospital of Anhui Medical Universitycollaborator
- Tongji Hospitalcollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
- Cancer Institute and Hospital, Chinese Academy of Medical Sciencescollaborator
- Peking Union Medical College Hospitalcollaborator
- The First Affiliated Hospital of Shanxi Medical Universitycollaborator
- Shanxi Provincial Cancer Hospitalcollaborator
- Changzhi Medical Collegecollaborator
- First Affiliated Hospital Xi'an Jiaotong Universitycollaborator
- Second Affiliated Hospital of Xi'an Jiaotong Universitycollaborator
- The First Affiliated Hospital of Air Force Medicial Universitycollaborator
- Tang-Du Hospitalcollaborator
- Quanzhou First Hospitalcollaborator
- Third Affiliated Hospital, Sun Yat-Sen Universitycollaborator
Study Sites (1)
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2022
First Posted
April 18, 2023
Study Start
August 1, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
April 18, 2023
Record last verified: 2023-04