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NCT03572283 · ClinicalTrials.gov registry record · Early Phase 1
Bethanechol Prior to Pancreatic Surgery
A Early Phase 1 study, sponsored by Columbia University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 17
- Enrollment target
NCT03572283: Completed Early Phase 1 study, sponsored by Columbia University.
NCT03572283 is a Early Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 17 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03572283, a Early Phase 1 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess the impact of bethanechol therapy on tumor activity by looking at biomarkers of proliferation, inflammation, and stem cell markers in post-treatment specimens compared to pre-treatment specimens and compared to other patients who were not treated with bethanechol prior to surgery. The investigators hypothesize that treatment with bethanechol will alter nerve conduction within tumors by stimulating the parasympathetic nervous system and reduce tumor proliferation, reduce macrophage activation, reduce tumor necrosis factor (TNF) alpha, and decrease human cluster of differentiation 44 (CD44) protein cancer stem cells. The safety objective is to assess the safety and tolerability of short course bethanechol prior to surgery and the impact of this treatment on immediate surgical outcomes. The investigators will assess all treatment-related toxicities with an emphasis on GI side effects and evaluate the impact of therapy on surgical delays or immediate post-op complications. All subjects will be contacted 1 week after beginning therapy to assess toxicity including GI specific toxicity and followed for safety for 30 days following completion of study medication. The investigators hypothesize that treatment for a minimum of 1 week will be tolerable in this selected patient population and will not interfere with progression to surgery or lead to increased surgical complications.
Primary Outcome
Individual tumor tissues will be evaluated, comparing pre-treatment and post-treatment samples. Percentage of change in proliferation/staining and standard deviation will be analyzed and calculated.
Interventions
- DRUG Bethanechol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2018-04-08 |
| Est. Completion | 2023-08-24 |
| Phase | Early Phase 1 |
What the finished NCT03572283 record still lists
NCT03572283 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which Bethanechol is the first listed.
NCT03572283 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03572283 about?
NCT03572283 is a clinical study titled "Bethanechol Prior to Pancreatic Surgery". The primary objective of this study is to assess the impact of bethanechol therapy on tumor activity by looking at biomarkers of proliferation, inflammation, and stem cell markers in post-treatment specimens compared to pre-treatment specimens and compared to other patients who were not treated with...
What is the current status of trial NCT03572283?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 17 participants. The study started on 2018-04-08. Estimated completion is 2023-08-24.
What interventions are being tested in trial NCT03572283?
The interventions under investigation include: Bethanechol (DRUG).
Who is sponsoring clinical trial NCT03572283?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03572283's enrollment target sits among peer trials
17 1350th of 2000 higher than 632 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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