Efficacy and Safety of Pseudomonas Aeruginosa for Intermediate and High-risk Non-muscle Invasive … (NCT05975151) | Clinical Trial Compass
UnknownPhase 2
Efficacy and Safety of Pseudomonas Aeruginosa for Intermediate and High-risk Non-muscle Invasive Bladder Cancer
China63 participantsStarted 2023-10-01
Plain-language summary
This is a multicenter, single-arm study to evaluate the efficacy and safety of Pseudomonas aeruginosa the treatment of patients with intermediate and high risk non-muscle invasive bladder cancer. The study continued treatment until the patient could not obtain clinical benefits or had intolerable toxic reactions or the patient withdrew the informed consent, whichever occurred first.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years old, both male and female;
. Diagnosed as Intermediate or high risk non-muscle invasive bladder cancer, with previous recurrent pathological diagnosis report and cystoscopy available. Intermediate risk was defined as the presence of one or two of the following: multiple tumors, single tumor larger than 3cm, and/or recurrence (≥1 event in low-risk NMIBC within 1 year after diagnosis). High risk was defined as meeting any one of the following: T1 tumor, G3 tumor, carcinoma in situ (CIS), multiple, recurrent and large (\> 3cm) TaG1G2/ low-risk tumor (simultaneous);
. Not receiving BCG or other immune drug infusion chemotherapy at the same time
. Informed consent and signed informed consent form by patients and their families;
. Clear consciousness and able to answer questions independently, Patients were asked to complete the questionnaire by themselves;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. No history of neurological diseases, severe hematological diseases, and dysfunction of heart, lung, liver, or kidney were observed.
Exclusion criteria
. Patients with other genitourinary system tumors or other organ tumors;
. Patients with muscle invasive bladder urothelial carcinoma (≥T2);
. Patients receiving chemotherapy, radiotherapy or immunotherapy within the past 4 weeks (excluding immediate postoperative intravesical chemotherapy);
. Pregnant or lactating women, women of childbearing age who did not use effective contraception, and those who planned to become pregnant during the trial (including the partner of male subjects);
. Known or suspected intraoperative bladder perforation;
. Gross hematuria was present before enrollment, and the surgical wound was suspected to be unhealed or damaged urinary mucosa;
. Patients with cystitis, or previous treatment with other intravesical agents, whose bladder irritation significantly affected the evaluation of the study;
. Patients who had participated in a clinical trial with other drugs within 3 months before enrollment;