Trial Title:
Application Circulating Tumor DNA Dynamic Monitoring in Clinical Treatment of Metastatic Renal Cell Carcinoma
NCT ID:
NCT05816642
Condition:
Metastatic Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Sunitinib
Axitinib
Immune Checkpoint Inhibitors
Conditions: Keywords:
metastatic renal cell carcinoma
molecular classification
ctDNA dynamic monitoring
targeted therapy
targeted therapy combined with immunotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
sunitinib or pazopanib
Description:
Single targeted therapy
Arm group label:
Single targeted therapy
Intervention type:
Drug
Intervention name:
PD-1 inhibitor combined with axitinib
Description:
targeted therapy combined with immunotherapy
Arm group label:
targeted therapy combined with immunotherapy
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- • 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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Address:
City:
Shanghai
Zip:
200127
Country:
China
Status:
Recruiting
Contact:
Last name:
wei xue, M.D
Phone:
86-21-68383776
Email:
xuewei@renji.com
Investigator:
Last name:
wei xue, M.D
Email:
Principal Investigator
Start date:
August 1, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Collaborator:
Agency:
Ruijin Hospital
Agency class:
Other
Collaborator:
Agency:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Collaborator:
Agency:
West China Hospital
Agency class:
Other
Collaborator:
Agency:
Xiangya Hospital of Central South University
Agency class:
Other
Collaborator:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Second Affiliated Hospital of Nantong University
Agency class:
Other
Collaborator:
Agency:
Peking University First Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Agency class:
Other
Collaborator:
Agency:
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Agency class:
Other
Collaborator:
Agency:
Zhejiang University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Wenzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Sir Run Run Shaw Hospital
Agency class:
Other
Collaborator:
Agency:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class:
Other
Collaborator:
Agency:
The General Hospital of Eastern Theater Command
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of University of Science and Technology of China
Agency class:
Other
Collaborator:
Agency:
The Second Hospital of Anhui Medical University
Agency class:
Other
Collaborator:
Agency:
Tongji Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Zhengzhou University
Agency class:
Other
Collaborator:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Shanxi Medical University
Agency class:
Other
Collaborator:
Agency:
Shanxi Provincial Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Changzhi Medical College
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
Second Affiliated Hospital of Xi'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
Xijing Hospital of Air Force Military Medical University
Agency class:
Other
Collaborator:
Agency:
Tang-Du Hospital
Agency class:
Other
Collaborator:
Agency:
Quanzhou First Hospital Affiliated to Fujian Medical University
Agency class:
Other
Collaborator:
Agency:
Third Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05816642
