RecruitingNCT06662071

A Research Protocol for Evaluating the Efficacy of Perfused Chemotherapeutic Agents for Bladder Cancer Based on Organoid Technology

A Research Protocol for Evaluating the Efficacy of Perfused Chemotherapeutic Agents for Bladder Cancer Based on Organoid technologyKYLL-202407-046-1


Sponsor

Qilu Hospital of Shandong University

Enrollment

293 participants

Start Date

Oct 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The investigators are here to invite participants to participate in a medical research project, and this informed consent form provides participants with information to decide whether or not to participate in this study. Please read the following carefully and discuss any questions and terms that are not clear with the study doctor. The participants' participation in this study is completely voluntary and the project has been reviewed by the Research Ethics Committee of Qilu Hospital, Shandong University.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether growing miniature versions of a patient's bladder tumor in the lab (called organoids) can help predict which chemotherapy drugs will work best when delivered directly into the bladder — a procedure called bladder perfusion therapy — for people with early-stage, non-muscle-invasive bladder cancer. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with intermediate or high-risk bladder cancer that has not spread into the muscle wall - You have not received prior bladder chemotherapy instillation treatment (except for a one-time dose right after surgery) - You are able to follow the study procedures and attend follow-up visits **You may NOT be eligible if...** - You had a bladder tear, major bleeding, or a serious bladder infection after your most recent surgery - You have a weakened immune system (e.g., HIV/AIDS, on immunosuppressive medications) - You are allergic to the study drugs - You have been taking hormonal drugs long-term or have a history of drug dependence - You are pregnant, breastfeeding, or planning a pregnancy soon - Your blood counts or organ function tests (liver, kidneys) are below acceptable levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEROrganoid culture

Organoid culture of tumor tissue obtained during patient surgery


Locations(17)

Binzhou Medical University Hospital

Binzhou, Shandong, China

Qilu Hospital of Shandong University Dezhou Hospital

Dezhou, Shandong, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Shandong Provincial Hospital Affiliated to Shandong First Medical University (Shandong Provincial Hospital)

Jinan, Shandong, China

Shandong Third Hospital

Jinan, Shandong, China

The First Affiliated Hospital Of Shandong First Medcial Unversity

Jinan, Shandong, China

The second hospital of Shandong University

Jinan, Shandong, China

Jining No.1 People's Hospital

Jining, Shandong, China

Liaocheng People's Hospital

Liaocheng, Shandong, China

Linyi People's Hospital

Linyi, Shandong, China

Qilu Hospital of Shandong University(Qing Dao)

Qingdao, Shandong, China

the Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Taian City Central Hospital

Taian, Shandong, China

Weifang People's Hospital

Weifang, Shandong, China

Yantai Yuhuanding Hospital

Yantai, Shandong, China

Zaozhuang Municipal Hospital

Zaozhuang, Shandong, China

Zibo Central Hospital

Zibo, Shandong, China

View Full Details on ClinicalTrials.gov

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NCT06662071


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