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NCT02326168 · ClinicalTrials.gov registry record · Early Phase 1
PRIME: Pilot Study Evaluating Percutaneous Vaccination of BCG for Bladder Cancer
A Early Phase 1 study, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 25
- Enrollment target
NCT02326168: Completed Early Phase 1 study, sponsored by The University of Texas Health Science Center at San Antonio.
NCT02326168 is a Early Phase 1 study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 25 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02326168, a Early Phase 1 study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
Approximately 25 subjects will be enrolled and receive a standard WHO adult potency BCG immunization (1cc/50mg live mycobacilli) in the deltoid. Following a wait period after BCG vaccination, patients will then receive standard strength BCG intravesical therapy once a week for a total of 6 weeks. The BCG is instilled and held in the bladder for approximately 2 hours. While the BCG is retained in the bladder the patient should be repositioned every 30 minutes to maximize bladder surface exposure to the agent. Patients will undergo a cystoscopy every 3 months following most recent TURBT. Study duration last approximately 6 months.
Primary Outcome
Percentage of patients with complete response at 3 months following therapy of combined percutaneous vaccination with TICE percutaneous Bacillus Calmette-Guerin (BCG) vaccine combined with standard protocol intravesical induction BCG vaccine for patients with non-muscle invasive transitional cell carcinoma of the bladder.
Interventions
- DRUG Bacillus Calmette-Guerin (BCG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2013-10 |
| Est. Completion | 2015-10 |
| Phase | Early Phase 1 |
What the finished NCT02326168 record still lists
NCT02326168 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which Bacillus Calmette-Guerin (BCG) is the first listed.
NCT02326168 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02326168 about?
NCT02326168 is a clinical study titled "PRIME: Pilot Study Evaluating Percutaneous Vaccination of BCG for Bladder Cancer". Approximately 25 subjects will be enrolled and receive a standard WHO adult potency BCG immunization (1cc/50mg live mycobacilli) in the deltoid. Following a wait period after BCG vaccination, patients will then receive standard strength BCG intravesical therapy once a week for a total of 6 weeks. Th...
What is the current status of trial NCT02326168?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 25 participants. The study started on 2013-10. Estimated completion is 2015-10.
What interventions are being tested in trial NCT02326168?
The interventions under investigation include: Bacillus Calmette-Guerin (BCG) (DRUG).
Who is sponsoring clinical trial NCT02326168?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02326168's enrollment target sits among peer trials
25 1000th of 2000 higher than 964 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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