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/NCT06026332</url>
    </required_header>
    <id_info>
      <org_study_id>000431</org_study_id>
      <nct_id>NCT06026332</nct_id>
    </id_info>
    <brief_title>ADSTILADRIN Early Utilization and Outcomes in the Real World Setting in the United States</brief_title>
    <acronym>ABLE-41</acronym>
    <official_title>ADSTILADRIN Early Utilization and Outcomes in the Real World Setting in the United States</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ferring Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ferring Pharmaceuticals</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Multi-center, prospective non-interventional study to collect data on the early use of&#xD;
        ADSTILADRIN in the US. Data will be collected from participants, caregivers and prescribing&#xD;
        physicians in a real-world setting.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 5, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Whether or not a patient with CIS (with or without concomitant high-grade Ta or T1 papillary disease) achieves Complete Response (CR) at first evaluation from first ADSTILADRIN instillation</measure>
      <time_frame>3 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Whether or not a patient with CIS (with or without concomitant high-grade Ta or T1 papillary disease) achieves CR at any time within 1 year from first ADSTILADRIN instillation</measure>
      <time_frame>1 year</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Duration of CR in patients with CIS (with or without concomitant high-grade Ta or T1 papillary disease) who achieve CR</measure>
      <time_frame>Up to 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>High-grade recurrence-free survival</measure>
      <time_frame>Up to 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of being HGRF after one ADSTILADRIN instillation and incidence of being HGRF at 1 year from first ADSTILADRIN instillation</measure>
      <time_frame>1 year</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of and time to cystectomy</measure>
      <time_frame>Up to 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>Up to 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (OS)</measure>
      <time_frame>Up to 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality due to bladder cancer</measure>
      <time_frame>Up to 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prior treatments and outcomes before starting ADSTILADRIN treatment</measure>
      <time_frame>Before starting ADSTILADRIN treatment</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of ADSTILADRIN instillations received and time intervals between instillations</measure>
      <time_frame>Up to 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reasons for discontinuation of ADSTILADRIN treatment</measure>
      <time_frame>End of trial (up to 2 years)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concomitant therapies for bladder cancer and major comorbidities</measure>
      <time_frame>Up to 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Re-treatment of non-responders with ADSTILADRIN at 3 months or when deemed appropriate by the treating physician</measure>
      <time_frame>3 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subsequent line of therapy following ADSTILADRIN discontinuation</measure>
      <time_frame>Up to 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Customized patient experience survey (before first ADSTILADRIN instillation and before each instillation thereafter)</measure>
      <time_frame>Before first ADSTILADRIN instillation and before each instillation thereafter</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patients' caregiver experience as measured by WPAI:CG (administered at the same timepoints as the patients)</measure>
      <time_frame>Up to 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Customized physician surveys (at 1 month following first patient first instillation of ADSTILADRIN, or as soon as possible upon site activation, and at 12 and 24 months post first patient first instillation at each respective site)</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Domains captured will include product considerations and treatment satisfaction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Type, incidence, relatedness to ADSTILADRIN, severity grading (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0), and seriousness of adverse events collected</measure>
      <time_frame>End of trial (up to 2 years)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with pre-specified biomarker tested in the routine care setting, along with timing, type of sampling and laboratory results</measure>
      <time_frame>End of trial (up to 2 years)</time_frame>
      <description>Routine care setting e.g., Cxbladder Detec, UroVysion FISH, nuclear matrix protein 22 (NMP22) and bladder tumor antigen (BTA) tests]</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">800</enrollment>
    <condition>Bladder Cancer</condition>
    <arm_group>
      <arm_group_label>ADSTILADRIN</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ADSTILADRIN</intervention_name>
      <description>Non-interventional</description>
      <arm_group_label>ADSTILADRIN</arm_group_label>
      <other_name>Nadofaragene Firadenovec</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Participants who have been prescribed Ferring ADSTILADRIN at the participating sites will&#xD;
          be enrolled.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Prescribed and scheduled treatment with ADSTILADRIN per physician discretion or&#xD;
               received the first instillation of ADSTILADRIN per physician discretion after 5&#xD;
               September 2023 but prior to site activation&#xD;
  &#xD;
            -  Signed and dated ICF.&#xD;
  &#xD;
            -  Age 18 years or older at day ICF is signed.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Currently enrolled in a clinical trial.&#xD;
  &#xD;
            -  Participants who have previously been treated with ADSTILADRIN in the context of a&#xD;
               clinical trial&#xD;
  &#xD;
            -  Participant is pregnant or breastfeeding.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Global Clinical Compliance</last_name>
      <role>Study Director</role>
      <affiliation>Ferring Pharmaceuticals</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Global Clinical Compliance</last_name>
      <phone>+1 833-548-1402 (US/Canada)</phone>
      <email>DK0-Disclosure@ferring.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Global Clinical Compliance</last_name>
      <phone>+1 862-286-5200 (outside US)</phone>
      <email>DK0-Disclosure@ferring.com</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Bladder cancer</keyword>
    <keyword>NMIBC</keyword>
    <keyword>CIS</keyword>
    <keyword>Ta/T1</keyword>
    <keyword>BCG Unresponsive</keyword>
    <keyword>Vesical instillation treatment</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06026332
  org study id: 000431
  nct id: NCT06026332
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  Multi-center, prospective non-interventional study to collect data on the early use of
        ADSTILADRIN in the US. Data will be collected from participants, caregivers and prescribing
        physicians in a real-world setting.
  observational model: Cohort
  time perspective: Prospective
  measure: Whether or not a patient with CIS (with or without concomitant high-grade Ta or T1 papillary disease) achieves Complete Response (CR) at first evaluation from first ADSTILADRIN instillation
  time frame: 3 months
  measure: Whether or not a patient with CIS (with or without concomitant high-grade Ta or T1 papillary disease) achieves CR at any time within 1 year from first ADSTILADRIN instillation
  time frame: 1 year
  measure: Duration of CR in patients with CIS (with or without concomitant high-grade Ta or T1 papillary disease) who achieve CR
  time frame: Up to 2 years
  measure: High-grade recurrence-free survival
  time frame: Up to 2 years
  measure: Incidence of being HGRF after one ADSTILADRIN instillation and incidence of being HGRF at 1 year from first ADSTILADRIN instillation
  time frame: 1 year
  measure: Incidence of and time to cystectomy
  time frame: Up to 2 years
  measure: Progression-free survival (PFS)
  time frame: Up to 2 years
  measure: Overall Survival (OS)
  time frame: Up to 2 years
  measure: Mortality due to bladder cancer
  time frame: Up to 2 years
  measure: Prior treatments and outcomes before starting ADSTILADRIN treatment
  time frame: Before starting ADSTILADRIN treatment
  measure: Number of ADSTILADRIN instillations received and time intervals between instillations
  time frame: Up to 2 years
  measure: Reasons for discontinuation of ADSTILADRIN treatment
  time frame: End of trial (up to 2 years)
  measure: Concomitant therapies for bladder cancer and major comorbidities
  time frame: Up to 2 years
  measure: Re-treatment of non-responders with ADSTILADRIN at 3 months or when deemed appropriate by the treating physician
  time frame: 3 months
  measure: Subsequent line of therapy following ADSTILADRIN discontinuation
  time frame: Up to 2 years
  measure: Customized patient experience survey (before first ADSTILADRIN instillation and before each instillation thereafter)
  time frame: Before first ADSTILADRIN instillation and before each instillation thereafter
  measure: Patients' caregiver experience as measured by WPAI:CG (administered at the same timepoints as the patients)
  time frame: Up to 2 years
  measure: Customized physician surveys (at 1 month following first patient first instillation of ADSTILADRIN, or as soon as possible upon site activation, and at 12 and 24 months post first patient first instillation at each respective site)
  time frame: Up to 2 years
  description: Domains captured will include product considerations and treatment satisfaction
  measure: Type, incidence, relatedness to ADSTILADRIN, severity grading (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0), and seriousness of adverse events collected
  time frame: End of trial (up to 2 years)
  measure: Proportion of patients with pre-specified biomarker tested in the routine care setting, along with timing, type of sampling and laboratory results
  time frame: End of trial (up to 2 years)
  description: Routine care setting e.g., Cxbladder Detec, UroVysion FISH, nuclear matrix protein 22 (NMP22) and bladder tumor antigen (BTA) tests]
  arm group label: ADSTILADRIN
  intervention type: Drug
  intervention name: ADSTILADRIN
  description: Non-interventional
  arm group label: ADSTILADRIN
  other name: Nadofaragene Firadenovec
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Global Clinical Compliance
  role: Study Director
  affiliation: Ferring Pharmaceuticals
  last name: Global Clinical Compliance
  phone: +1 833-548-1402 (US/Canada)
  email: DK0-Disclosure@ferring.com
  last name: Global Clinical Compliance
  phone: +1 862-286-5200 (outside US)
  email: DK0-Disclosure@ferring.com
  responsible party type: Sponsor
  mesh term: Urinary Bladder Neoplasms
  sharing ipd: No