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Application Circulating Tumor DNA Dynamic Monitoring in Clinical Treatment of Metastatic Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05816642
Recruitment Status : Recruiting
First Posted : April 18, 2023
Last Update Posted : April 18, 2023
Sponsor:
Collaborators:
Ruijin Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
West China Hospital
Xiangya Hospital of Central South University
Fudan University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Second Affiliated Hospital of Nantong University
Peking University First Hospital
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Zhejiang University
First Affiliated Hospital of Wenzhou Medical University
Sir Run Run Shaw Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The General Hospital of Eastern Theater Command
The First Affiliated Hospital with Nanjing Medical University
The First Affiliated Hospital of University of Science and Technology of China
The Second Hospital of Anhui Medical University
Tongji Hospital
The First Affiliated Hospital of Zhengzhou University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Peking Union Medical College Hospital
The First Affiliated Hospital of Shanxi Medical University
Shanxi Provincial Cancer Hospital
Changzhi Medical College
First Affiliated Hospital Xi'an Jiaotong University
Second Affiliated Hospital of Xi'an Jiaotong University
Xijing Hospital of Air Force Military Medical University
Tang-Du Hospital
Quanzhou First Hospital Affiliated to Fujian Medical University
Third Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
RenJi Hospital

Tracking Information
First Submitted Date  ICMJE October 22, 2022
First Posted Date  ICMJE April 18, 2023
Last Update Posted Date April 18, 2023
Actual Study Start Date  ICMJE August 1, 2022
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2023)		 progression-free survival [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2023)		 Objective Response Rate [ Time Frame: From drug taken until the date of first documented progression, assessed up to 20 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Application Circulating Tumor DNA Dynamic Monitoring in Clinical Treatment of Metastatic Renal Cell Carcinoma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Metastatic Renal Cell Carcinoma
Intervention  ICMJE
  • Drug: sunitinib or pazopanib
    Single targeted therapy
  • Drug: PD-1 inhibitor combined with axitinib
    targeted therapy combined with immunotherapy
Study Arms  ICMJE
  • Active Comparator: Single targeted therapy
    sunitinib or pazopanib
    Intervention: Drug: sunitinib or pazopanib
  • Experimental: targeted therapy combined with immunotherapy
    Programmed death-ligand 1 Inhibitor combined with axitinib
    Intervention: Drug: PD-1 inhibitor combined with axitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2023)		 500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: wei xue 86-21-68383776 xuewei@renji.com
Contact: jiwei huang, M.D 8613651682825 huangjiwei@renji.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05816642
Other Study ID Numbers  ICMJE MRCC-China collaboration
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party RenJi Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE RenJi Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Ruijin Hospital
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  • West China Hospital
  • Xiangya Hospital of Central South University
  • Fudan University
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Second Affiliated Hospital of Nantong University
  • Peking University First Hospital
  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital
  • Zhejiang University
  • First Affiliated Hospital of Wenzhou Medical University
  • Sir Run Run Shaw Hospital
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • The General Hospital of Eastern Theater Command
  • The First Affiliated Hospital with Nanjing Medical University
  • The First Affiliated Hospital of University of Science and Technology of China
  • The Second Hospital of Anhui Medical University
  • Tongji Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Peking Union Medical College Hospital
  • The First Affiliated Hospital of Shanxi Medical University
  • Shanxi Provincial Cancer Hospital
  • Changzhi Medical College
  • First Affiliated Hospital Xi'an Jiaotong University
  • Second Affiliated Hospital of Xi'an Jiaotong University
  • Xijing Hospital of Air Force Military Medical University
  • Tang-Du Hospital
  • Quanzhou First Hospital Affiliated to Fujian Medical University
  • Third Affiliated Hospital, Sun Yat-Sen University
Investigators  ICMJE Not Provided
PRS Account RenJi Hospital
Verification Date April 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP