Clinical trial · Observational
ADSTILADRIN Early Utilization and Outcomes in the Real World Setting
NCT06026332CI-TRIAL-00103477ABLE-41terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): An internal audit identified major inconsistencies and missing data in key registry fields, including primary outcomes. These issues mean we can no longer ensure the validity of the primary endpoints.
Summary
Brief summary (as posted)
Multi-center, prospective non-interventional study to collect data on the early use of Adstiladrin in the US and Israel. Data will be collected from patients and prescribing physicians in a real-world setting
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADSTILADRIN | Drug | Nadofaragene Firadenovec | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- ADSTILADRIN
- interventionNames
- Drug: ADSTILADRIN
Primary outcomes (2)
- 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
- timeFrame
- 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
- timeFrame
- 1 year
Secondary outcomes (19)
- measure
- Duration of CR in patients with CIS (with or without concomitant high-grade Ta or T1 papillary disease) who achieve CR
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.