Collecting data on early use of Adstiladrin for bladder cancer
ADSTILADRIN Early Utilization and Outcomes in the Real World Setting
Ferring Pharmaceuticals · NCT06026332
This study is collecting information from patients and doctors to see how well the bladder cancer treatment Adstiladrin works and how safe it is for people who started using it after September 5, 2023.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ferring Pharmaceuticals (industry) |
| Locations | 21 sites (Gilbert, Arizona and 20 other locations) |
| Trial ID | NCT06026332 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world data on the early utilization of Adstiladrin in patients with bladder cancer across multiple centers in the US and Israel. It involves collecting information from both patients and prescribing physicians to assess the treatment's outcomes. The study focuses on patients who have been prescribed Adstiladrin after September 5, 2023, and aims to provide insights into its effectiveness and safety in a non-interventional setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been prescribed Adstiladrin for bladder cancer treatment.
Not a fit: Patients currently enrolled in another clinical trial or those who have previously received Adstiladrin in a clinical trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the effectiveness of Adstiladrin for patients with bladder cancer, potentially leading to improved treatment strategies.
How similar studies have performed: While this study is observational and focuses on real-world data, similar studies have shown promise in evaluating treatment outcomes for bladder cancer therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Prescribed and scheduled treatment with ADSTILADRIN per physician discretion or received the first instillation of ADSTILADRIN per physician discretion after 5 September 2023 but prior to site activation * Signed and dated ICF. * Age 18 years or older at day ICF is signed. Exclusion Criteria: * Currently enrolled in a clinical trial. * Participants who have previously been treated with ADSTILADRIN in the context of a clinical trial * Participant is pregnant or breastfeeding.
Where this trial is running
Gilbert, Arizona and 20 other locations
- Ferring Investigational Site — Gilbert, Arizona, United States (RECRUITING)
- Ferring Investigational Site — Little Rock, Arkansas, United States (RECRUITING)
- Ferring Investigational Site — Fresno, California, United States (RECRUITING)
- Ferring Investigational Site — Los Angeles, California, United States (RECRUITING)
- Ferring Investigational Site — Gainesville, Florida, United States (RECRUITING)
- Ferring Investigational Site — Atlanta, Georgia, United States (RECRUITING)
- Ferring Investigational Site — Greenwood, Indiana, United States (RECRUITING)
- Ferring Investigational Site — Jeffersonville, Indiana, United States (RECRUITING)
- Ferring Investigational Site — Wichita, Kansas, United States (RECRUITING)
- Ferring Investigational Site — Baltimore, Maryland, United States (RECRUITING)
- Ferring Investigational Site — Rochester, Minnesota, United States (RECRUITING)
- Ferring Investigational Site — Omaha, Nebraska, United States (RECRUITING)
- Ferring Investigational Site — Bronx, New York, United States (RECRUITING)
- Ferring Investigational Site — New York, New York, United States (RECRUITING)
- Ferring Investigational Site — Syracuse, New York, United States (RECRUITING)
- Ferring Investigational Site — Gahanna, Ohio, United States (RECRUITING)
- Ferring Investigational Site — Myrtle Beach, South Carolina, United States (RECRUITING)
- Ferring Investigational Site — Nashville, Tennessee, United States (RECRUITING)
- Ferring Investigation Site — Dallas, Texas, United States (RECRUITING)
- Ferring Investigational Site — Charlottesville, Virginia, United States (RECRUITING)
- Ferring Investigational Site — Virginia Beach, Virginia, United States (RECRUITING)
Study contacts
- Study coordinator: Global Clinical Compliance
- Email: MedqueriesUS@ferring.com
- Phone: 1-888-FERRING (1-888-337-7464)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bladder Cancer, Bladder cancer, NMIBC, CIS, Ta/T1, BCG Unresponsive, Vesical instillation treatment