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

Recruiting now

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID

NCT06662071

Run by

Qilu Hospital of Shandong University

People needed

293

Starts

2024-10-01

Expected to finish

2028-09-30

Last updated by the study team

2024-10-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-80 years old, gender is not limited;
• Patients with intermediate-risk and high-risk non-muscle invasive bladder cancer (NMIBC) requiring bladder perfusion therapy;
• No prior bladder perfusion therapy (except immediate postoperative perfusion);
• ECOG status score of 0-2;
• Be able to comply with the trial protocol, have good compliance, cooperate in observing adverse events and efficacy and cooperate in follow-up, as judged by the investigator;
• Voluntarily participate in this clinical trial, understand the study procedures and have signed the informed consent to participate in this study;

You may not qualify if…

• bladder perforation during TURBT, postoperative gross haematuria, symptomatic severe chemical cystitis, and urinary tract infection;
• Immunodeficient or damaged individuals (e.g., AIDS patients, patients on immunosuppressive drugs or radiotherapy);
• Subjects with known allergies or sensitivities to the study drug, analogues, excipients, etc.
• Subjects who have been taking hormonal drugs for a long period of time or have a history of drug abuse and dependence
• Those who have recent pregnancy plans or are already pregnant or breastfeeding;
• Those with abnormal blood counts, liver and kidney functions and coagulation indexes: (fulfilling 1 or more can be considered abnormal)
• ① Neutrophil count (ANC) ≤1.5×10*9/L;
• white blood cell count (WBC) ≤ 3.0 × 10*9 / L.
• Platelet count (PLT) ≤90×10*9/L;
• Haemoglobin (HB) ≤90g/L; ⑤ Total bilirubin (TBIL) ≥1.5 × institutional upper limit of normal (ULN);
• Estimated glomerular filtration rate (eGFR) ≤30 ml/min/1.73m²;
• International Normalised Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≥ ULN (except for patients receiving anticoagulation therapy, subject to the investigator's opinion that this is a clinically acceptable outcome)
• The subject has other factors that may force the study to be terminated mid-stream, such as:
• The patient has a previous or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML);
• A previous history of a definite neurological or psychiatric disorder, including epilepsy or dementia;
• Serious concomitant medical conditions (e.g., severe hypertension, diabetes mellitus, thyroid disease, etc.) that jeopardise patient safety, or interfere with the patient's ability to complete the study; ④ Other serious diseases requiring combination therapy, with serious laboratory test abnormalities; ⑤ Other serious diseases accompanied by family or social factors, etc., which will affect the safety of the subjects, or the collection of data and samples, etc; ⑥ Uncontrolled co-morbidities including, but not limited to, persistent or active infections requiring treatment, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmias.
• In the opinion of the investigator, not suitable for participation in this study.

Where it is running

• Binzhou Medical University Hospital — Binzhou, Shandong, China (enrolling)
• Qilu Hospital of Shandong University Dezhou Hospital — Dezhou, Shandong, China (enrolling)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (enrolling)
• Shandong Provincial Hospital Affiliated to Shandong First Medical University (Shandong Provincial Hospital) — Jinan, Shandong, China (enrolling)
• Shandong Third Hospital — Jinan, Shandong, China (enrolling)
• The First Affiliated Hospital Of Shandong First Medcial Unversity — Jinan, Shandong, China (enrolling)
• The second hospital of Shandong University — Jinan, Shandong, China (enrolling)
• Jining No.1 People's Hospital — Jining, Shandong, China (enrolling)
• Liaocheng People's Hospital — Liaocheng, Shandong, China (enrolling)
• Linyi People's Hospital — Linyi, Shandong, China (enrolling)
• Qilu Hospital of Shandong University(Qing Dao) — Qingdao, Shandong, China (enrolling)
• the Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (enrolling)
• Taian City Central Hospital — Taian, Shandong, China (enrolling)
• Weifang People's Hospital — Weifang, Shandong, China (enrolling)
• Yantai Yuhuanding Hospital — Yantai, Shandong, China (enrolling)
• Zaozhuang Municipal Hospital — Zaozhuang, Shandong, China (enrolling)
• Zibo Central Hospital — Zibo, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.