Clinical trial NCT05816642: Application Circulating Tumor DNA Dynamic Monitoring in Clinical Treatment of Metastatic Renal Cell Carcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metastatic Renal Cell Carcinoma
Keywords: metastatic renal cell carcinoma
molecular classification
ctDNA dynamic monitoring
targeted therapy
targeted therapy combined with immunotherapy
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: West China Hospital
name: Xiangya Hospital of Central South University
name: Fudan University
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Second Affiliated Hospital of Nantong University
name: Peking University First Hospital
name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
name: Zhejiang University
name: First Affiliated Hospital of Wenzhou Medical University
name: Sir Run Run Shaw Hospital
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: The General Hospital of Eastern Theater Command
name: The First Affiliated Hospital with Nanjing Medical University
name: The First Affiliated Hospital of University of Science and Technology of China
name: The Second Hospital of Anhui Medical University
name: Tongji Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Peking Union Medical College Hospital
name: The First Affiliated Hospital of Shanxi Medical University
name: Shanxi Provincial Cancer Hospital
name: Changzhi Medical College
name: First Affiliated Hospital Xi'an Jiaotong University
name: Second Affiliated Hospital of Xi'an Jiaotong University
name: The First Affiliated Hospital of Air Force Medicial University
name: Tang-Du Hospital
name: Quanzhou First Hospital
name: Third Affiliated Hospital, Sun Yat-Sen University
First posted: 2023-04-18
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: progression-free survival
timeFrame: 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:
measure: Objective Response Rate
timeFrame: From drug taken until the date of first documented progression, assessed up to 20 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
References: