Tests chemotherapy drugs on bladder cancer tissue grown in the lab
Uses lab-grown bladder cancer tissue to study chemotherapy drugs in adults 18 to 80.
Plain-language title generated from the registry record
Registry title: A Research Protocol for Evaluating the Efficacy of Perfused Chemotherapeutic Agents for Bladder Cancer Based on Organoid Technology
Key facts
- Where
- Binzhou, Dezhou, Jinan, Jining, Liaocheng, Linyi, Qingdao, Taian, Weifang, Yantai, Zaozhuang, and Zibo, ChinaSee the 17 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06662071, who can take part
Where in China
- Binzhou Medical University HospitalBinzhou, ChinaTaking people
- Qilu Hospital of Shandong University Dezhou HospitalDezhou, ChinaTaking people
- Qilu Hospital of Shandong UniversityJinan, ChinaTaking people
- Shandong Provincial Hospital Affiliated to Shandong First Medical University（Shandong Provincial Hospital）Jinan, ChinaTaking people
- Shandong Third HospitalJinan, ChinaTaking people
- The First Affiliated Hospital Of Shandong First Medcial UnversityJinan, ChinaTaking people
- The Second Hospital of Shandong UniversityJinan, ChinaTaking people
- Jining No. 1 People's Hospital.Jining, ChinaTaking people
- Liaocheng People's HospitalLiaocheng, ChinaTaking people
- Linyi People's HospitalLinyi, ChinaTaking people
- Qilu Hospital of Shandong University(Qing Dao)Qingdao, ChinaTaking people
- The Affiliated Hospital of Qingdao UniversityQingdao, ChinaTaking people
- Taian City Central HospitalTaian, ChinaTaking people
- Weifang People's HospitalWeifang, ChinaTaking people
- Yantai Yuhuanding HospitalYantai, ChinaTaking people
- Zaozhuang Municipal HospitalZaozhuang, ChinaTaking people
- Zibo Central hospitalZibo, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Qilu Hospital of Shandong University
- Trial code
- NCT06662071
- Record updated
- 28 October 2024
- Original description
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.Read full original descriptionShow less
A Research Protocol for Evaluating the Efficacy of Perfused Chemotherapeutic Agents for Bladder Cancer Based on Organoid technologyKYLL-202407-046-1
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.
Inclusion: 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.
Exclusion: Immunodeficient or damaged individuals (e.g., AIDS patients, patients on immunosuppressive drugs or radiotherapy); bladder perforation during TURBT, postoperative gross haematuria, symptomatic severe chemical cystitis, and urinary tract infection; 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 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; Those who have recent pregnancy plans or are already pregnant or breastfeeding; In the opinion of the investigator, not suitable for participation in this study.