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NCT02250014 · ClinicalTrials.gov registry record · Phase 1
The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer
A Phase 1 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT02250014: Completed Phase 1 study, sponsored by University of Colorado, Denver.
NCT02250014 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02250014, a Phase 1 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
This randomized pilot phase I trial studies how well sargramostim after cryotherapy works in treating patients with prostate cancer. Biological therapies, such as sargramostim, use substances made from living organisms that may stimulate the immune system in different ways and stop tumor cells from growing. Cryosurgery, also known as cryotherapy, kills tumor cells by freezing them. Giving sargramostim after cryotherapy may work better in treating prostate cancer.
Primary Outcome
A scatter plot of each cytokine and antigen level will be created for each patient by marker to observe the behavior of the markers (rising, falling, flat, or combination over time). Patient specific pre-operative levels will be used to obtain individual baseline measures from which the difference in follow-up cytokine and antigen levels will be calculated, then a simple descriptive comparison of the mean elevation in the markers' levels across cohorts will be graphed.
Interventions
- BIOLOGICAL sargramostim
- PROCEDURE cryotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2015-10-05 |
| Est. Completion | 2020-12-21 |
| Phase | Phase 1 |
What the finished NCT02250014 record still lists
NCT02250014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which sargramostim is the first listed.
NCT02250014 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02250014 about?
NCT02250014 is a clinical study titled "The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer". This randomized pilot phase I trial studies how well sargramostim after cryotherapy works in treating patients with prostate cancer. Biological therapies, such as sargramostim, use substances made from living organisms that may stimulate the immune system in different ways and stop tumor cells from ...
What is the current status of trial NCT02250014?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2015-10-05. Estimated completion is 2020-12-21.
What interventions are being tested in trial NCT02250014?
The interventions under investigation include: sargramostim (BIOLOGICAL), cryotherapy (PROCEDURE).
Who is sponsoring clinical trial NCT02250014?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02250014's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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