xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05975151</url>
    </required_header>
    <id_info>
      <org_study_id>bks02</org_study_id>
      <nct_id>NCT05975151</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Pseudomonas Aeruginosa for Intermediate and High-risk Non-muscle Invasive Bladder Cancer</brief_title>
    <official_title>Efficacy and Safety of Pseudomonas Aeruginosa Followed by Postoperative Intravesical Instillation in Patients With Intermediate and High-risk Non-muscle Invasive Bladder Cancer: a Multi-center, Single-arm Clinical Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Qilu Hospital of Shandong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Qilu Hospital of Shandong University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a multicenter, single-arm study to evaluate the efficacy and safety of Pseudomonas&#xD;
        aeruginosa the treatment of patients with intermediate and high risk non-muscle invasive&#xD;
        bladder cancer. The study continued treatment until the patient could not obtain clinical&#xD;
        benefits or had intolerable toxic reactions or the patient withdrew the informed consent,&#xD;
        whichever occurred first.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study used a multicenter open single-arm study design. Study start: March 2023 Study&#xD;
        end: March 2024 Multi-center: Three centers were selected to conduct the study to avoid&#xD;
        differences in efficacy due to differences in operation among centers. Single-arm study: A&#xD;
        total of 63 subjects with intermediate-high risk NMIBC who were scheduled for transurethral&#xD;
        resection of bladder tumor (TURBT) from March 2023 in three centers were enrolled in this&#xD;
        study. The enrolled patients received submucosal injection of 1U of Pseudomonas aeruginosa&#xD;
        injection and bladder irrigation with chemotherapy drugs (gemcitabine, mitomycin C,&#xD;
        epirubicin or pirarubicin) immediately after TURBT. After urine was cleared, a sterile&#xD;
        urinary catheter was placed, and 10U of Pseudomonas aeruginosa injection and 40ml of normal&#xD;
        saline were injected. The perfusion solution was kept for 1 hour, and the position was&#xD;
        changed every 20 minutes. The treatment was given once within 24 hours after operation, then&#xD;
        once a week for 12 weeks, and then once a month for 12 months in total. Patients were&#xD;
        followed up every 3 months after surgery. The last follow-up was completed in February 2025.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>recurrence rate</measure>
      <time_frame>1 year</time_frame>
      <description>Recurrence rate is determined on the basis of cystoscopy</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Disease-free survival</measure>
      <time_frame>1 year</time_frame>
      <description>Disease-free survival is defined as the time from the start of study treatment to disease recurrence or death from any cause</description>
    </secondary_outcome>
    <other_outcome>
      <measure>adverse event</measure>
      <time_frame>2 year</time_frame>
      <description>Adverse events including lower urinary tract symptoms, fever, and gastrointestinal reactions were evaluated according to laboratory and clinical tests (i.e., hematology and blood chemistry, urinalysis, and vital signs) during the observation period</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">63</enrollment>
    <condition>Bladder Cancer</condition>
    <arm_group>
      <arm_group_label>Pseudomonas aeruginosa Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pseudomonas aeruginosa</intervention_name>
      <description>A total of 63 subjects with intermediate and high risk NMIBC who were scheduled for transurethral resection of bladder tumor (TURBT) from March 2023 in three centers were enrolled in this study. The enrolled patients received submucosal injection of 1U of Pseudomonas aeruginosa injection and bladder irrigation with chemotherapy drugs (gemcitabine, mitomycin C, epirubicin or pirarubicin) immediately after TURBT. After urine was cleared, a sterile urinary catheter was placed, and 10U of Pseudomonas aeruginosa injection and 40ml of normal saline were injected. The perfusion solution was kept for 1 hour, and the position was changed every 20 minutes. The treatment was given once within 24 hours after operation, then once a week for 12 weeks, and then once a month for 12 months in total. Patients were followed up every 3 months after surgery. The last follow-up was completed in February 2025</description>
      <arm_group_label>Pseudomonas aeruginosa Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            1. Age ≥18 years old, both male and female;&#xD;
  &#xD;
            2. Diagnosed as Intermediate or high risk non-muscle invasive bladder cancer, with&#xD;
               previous recurrent pathological diagnosis report and cystoscopy available.&#xD;
               Intermediate risk was defined as the presence of one or two of the following: multiple&#xD;
               tumors, single tumor larger than 3cm, and/or recurrence (≥1 event in low-risk NMIBC&#xD;
               within 1 year after diagnosis). High risk was defined as meeting any one of the&#xD;
               following: T1 tumor, G3 tumor, carcinoma in situ (CIS), multiple, recurrent and large&#xD;
               (&amp;gt; 3cm) TaG1G2/ low-risk tumor (simultaneous);&#xD;
  &#xD;
            3. Not receiving BCG or other immune drug infusion chemotherapy at the same time&#xD;
  &#xD;
            4. Informed consent and signed informed consent form by patients and their families;&#xD;
  &#xD;
            5. Clear consciousness and able to answer questions independently, Patients were asked to&#xD;
               complete the questionnaire by themselves;&#xD;
  &#xD;
            6. No history of neurological diseases, severe hematological diseases, and dysfunction of&#xD;
               heart, lung, liver, or kidney were observed.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            1. Patients with other genitourinary system tumors or other organ tumors;&#xD;
  &#xD;
            2. Patients with muscle invasive bladder urothelial carcinoma (≥T2);&#xD;
  &#xD;
            3. Patients receiving chemotherapy, radiotherapy or immunotherapy within the past 4 weeks&#xD;
               (excluding immediate postoperative intravesical chemotherapy);&#xD;
  &#xD;
            4. Pregnant or lactating women, women of childbearing age who did not use effective&#xD;
               contraception, and those who planned to become pregnant during the trial (including&#xD;
               the partner of male subjects);&#xD;
  &#xD;
            5. Known or suspected intraoperative bladder perforation;&#xD;
  &#xD;
            6. Gross hematuria was present before enrollment, and the surgical wound was suspected to&#xD;
               be unhealed or damaged urinary mucosa;&#xD;
  &#xD;
            7. Patients with cystitis, or previous treatment with other intravesical agents, whose&#xD;
               bladder irritation significantly affected the evaluation of the study;&#xD;
  &#xD;
            8. Patients who had participated in a clinical trial with other drugs within 3 months&#xD;
               before enrollment;&#xD;
  &#xD;
            9. Patients with known opioid or alcohol dependence;&#xD;
  &#xD;
           10. Patients with any condition considered by the investigators to increase the risk of&#xD;
               the subject or interfere with the conduct of the trial;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Benkang Shi, Dr.</last_name>
      <phone>18560083917</phone>
      <email>bkang68@sdu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Qilu hospital</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>276600</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Benkang Shi</last_name>
        <phone>bkang68@sdu.edu.cn</phone>
        <email>bkang68@sdu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>bladder cancer</keyword>
    <keyword>NMIBC</keyword>
    <keyword>Pseudomonas aeruginosa</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pseudomonas Infections</mesh_term>
      <mesh_term>Urinary Bladder Neoplasms</mesh_term>
      <mesh_term>Non-Muscle Invasive Bladder Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05975151
  org study id: bks02
  nct id: NCT05975151
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  This study used a multicenter open single-arm study design. Study start: March 2023 Study
        end: March 2024 Multi-center: Three centers were selected to conduct the study to avoid
        differences in efficacy due to differences in operation among centers. Single-arm study: A
        total of 63 subjects with intermediate-high risk NMIBC who were scheduled for transurethral
        resection of bladder tumor (TURBT) from March 2023 in three centers were enrolled in this
        study. The enrolled patients received submucosal injection of 1U of Pseudomonas aeruginosa
        injection and bladder irrigation with chemotherapy drugs (gemcitabine, mitomycin C,
        epirubicin or pirarubicin) immediately after TURBT. After urine was cleared, a sterile
        urinary catheter was placed, and 10U of Pseudomonas aeruginosa injection and 40ml of normal
        saline were injected. The perfusion solution was kept for 1 hour, and the position was
        changed every 20 minutes. The treatment was given once within 24 hours after operation, then
        once a week for 12 weeks, and then once a month for 12 months in total. Patients were
        followed up every 3 months after surgery. The last follow-up was completed in February 2025.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: recurrence rate
  time frame: 1 year
  description: Recurrence rate is determined on the basis of cystoscopy
  measure: Disease-free survival
  time frame: 1 year
  description: Disease-free survival is defined as the time from the start of study treatment to disease recurrence or death from any cause
  measure: adverse event
  time frame: 2 year
  description: Adverse events including lower urinary tract symptoms, fever, and gastrointestinal reactions were evaluated according to laboratory and clinical tests (i.e., hematology and blood chemistry, urinalysis, and vital signs) during the observation period
  arm group label: Pseudomonas aeruginosa Group
  arm group type: Experimental
  intervention type: Drug
  intervention name: Pseudomonas aeruginosa
  description: A total of 63 subjects with intermediate and high risk NMIBC who were scheduled for transurethral resection of bladder tumor (TURBT) from March 2023 in three centers were enrolled in this study. The enrolled patients received submucosal injection of 1U of Pseudomonas aeruginosa injection and bladder irrigation with chemotherapy drugs (gemcitabine, mitomycin C, epirubicin or pirarubicin) immediately after TURBT. After urine was cleared, a sterile urinary catheter was placed, and 10U of Pseudomonas aeruginosa injection and 40ml of normal saline were injected. The perfusion solution was kept for 1 hour, and the position was changed every 20 minutes. The treatment was given once within 24 hours after operation, then once a week for 12 weeks, and then once a month for 12 months in total. Patients were followed up every 3 months after surgery. The last follow-up was completed in February 2025
  arm group label: Pseudomonas aeruginosa Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Benkang Shi, Dr.
  phone: 18560083917
  email: bkang68@sdu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Pseudomonas Infections
  mesh term: Urinary Bladder Neoplasms
  mesh term: Non-Muscle Invasive Bladder Neoplasms