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Study Protocol for Evaluating the Efficacy of Postoperative Adjuvant Chemotherapy Drugs for Bladder Cancer Based on Organoid Technology.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

To evaluate the clinical efficacy of using tumor organoid drug sensitivity experiments to guide postoperative adjuvant chemotherapy in patients with muscle-invasive bladder cancer, and to assess the application value of tumor organoid drug sensitivity experiments in guiding individualized postoperative adjuvant chemotherapy for muscle-invasive bladder cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 1\. Age between 18 and 80 years, any gender; 2. For patients undergoing radical cystectomy, if the pathology meets inclusion criterion No. 3, tissue from the surgical specimen will be used for organoid culture; 3. Patients with pT3-pT4 and/or lymph node-positive MIBC who require adjuvant chemotherapy after surgery; 4. Patients who can tolerate platinum-based chemotherapy; 5. ECOG performance status of 0-2; 6. According to the investigator's judgment, able to comply with the study protocol, demonstrate good adherence, cooperate with the monitoring of adverse events and efficacy, and comply with follow-up; 7. Willing to voluntarily participate in this clinical trial, understand the study procedures, and have signed the informed consent form to participate in this study.

Locations
Other Locations
China
Qilu Hospital of Shandong University
RECRUITING
Jinan
Contact Information
Primary
Jun Chen
chenjunxinxiang@163.com
+86 18560084873
Backup
Jingchao Liu
15665785012@163.com
+86 18560086740
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 266
Treatments
Experimental group
Using tumor organoid drug sensitivity experiments to test the sensitivity of a patient's tumor cells to seven chemotherapy drugs and formulate a postoperative adjuvant chemotherapy plan.
Control group
Select bladder cancer patients who underwent surgery during the same period and received postoperative adjuvant chemotherapy according to the empirical regimen as the control group.
Related Therapeutic Areas
Sponsors
Collaborators: Dezhou Hospital Qilu Hospital of Shandong University, The Second Hospital of Shandong University, Liaocheng People's Hospital, Jining First People's Hospital, Weifang People's Hospital, Taian City Central Hospital, The Affiliated Hospital of Qingdao University, Qianfoshan Hospital, Zibo Central Hospital, Binzhou Medical University, Zaozhuang Municipal Hospital, Yantai Yuhuangding Hospital, Linyi People's Hospital, Shandong Province Third hospital, Qilu Hospital of Shandong University (Qingdao), Shandong Provincial Hospital
Leads: Qilu Hospital of Shandong University

This content was sourced from clinicaltrials.gov