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NCT06320990 · ClinicalTrials.gov registry record · Phase 1
Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection
A Phase 1 study of Pancreatic Cyst and Pancreatic Mucinous Cystic Neoplasm, sponsored by University of Nebraska.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT06320990: Recruiting Phase 1 study of Pancreatic Cyst and Pancreatic Mucinous Cystic Neoplasm, sponsored by University of Nebraska.
NCT06320990 is a Phase 1 study of Pancreatic Cyst and Pancreatic Mucinous Cystic Neoplasm that is actively recruiting participants, run by University of Nebraska. The registered enrollment target is 15 participants, below the 549-participant average among 18 other Pancreatic Cyst trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06320990, a Phase 1 study of Pancreatic Cyst and Pancreatic Mucinous Cystic Neoplasm, is actively recruiting participants, sponsored by University of Nebraska.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Pancreatic mucinous cystic neoplasm (MCN) is a precursor to invasive pancreatic adenocarcinoma which occurs almost exclusively in females in their 5th-7th decade. Currently the only option for MCN treatment and prevention of invasive pancreatic ductal adenocarcinoma (PDA) is oncologic resection. The clinical features of pancreatic MCN support the influence of sex hormones in the pathogenesis of the disease. Anti-hormonal therapy may therefore constitute an effective approach to treatment. Preliminary analyses from preclinical studies suggest that tamoxifen inhibits the spread and normal life cycle in MCN epithelial cells and fibroblasts. Investigators hypothesize that in humans, treatment with tamoxifen will lead to cyst regression or stabilization and may spare or delay the need for resection. Up to 15 participants not undergoing immediate resection will be enrolled and take tamoxifen orally for up to 24 weeks. The study will assess the feasibility of tamoxifen as a treatment for pancreatic MCN.
Primary Outcome
Adherence rate, defined as the proportion of participants who take ≥70% of the prescribed tamoxifen doses with adherence at least 60%, meaning ≥60% of participants take ≥70% of the prescribed tamoxifen doses.
Conditions Studied
Interventions
- DRUG Tamoxifen 20mg
Study Locations (1)
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-01-22 |
| Est. Completion | 2027-05 |
| Phase | Phase 1 |
What NCT06320990 shows while recruiting
NCT06320990 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 549-participant average among 18 other Pancreatic Cyst trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Pancreatic Cyst appearing as the primary indexed condition, and to 1 intervention - of which Tamoxifen 20mg is the first listed.
NCT06320990 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT06320990 about?
NCT06320990 is a clinical study titled "Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection". Pancreatic mucinous cystic neoplasm (MCN) is a precursor to invasive pancreatic adenocarcinoma which occurs almost exclusively in females in their 5th-7th decade. Currently the only option for MCN treatment and prevention of invasive pancreatic ductal adenocarcinoma (PDA) is oncologic resection. The...
What is the current status of trial NCT06320990?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2025-01-22. Estimated completion is 2027-05.
What conditions does trial NCT06320990 study?
This clinical trial studies the following conditions: Pancreatic Cyst, Pancreatic Mucinous Cystic Neoplasm.
What interventions are being tested in trial NCT06320990?
The interventions under investigation include: Tamoxifen 20mg (DRUG).
Who is sponsoring clinical trial NCT06320990?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06320990 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06320990's enrollment target sits among peer trials
15 19th of 18 the lowest of 18 other Pancreatic Cyst trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Cyst 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.
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