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NCT03467789 · ClinicalTrials.gov registry record · Phase 1
Vitamin D as a Nutritional Neoadjuvant During Photodynamic Therapy of Basal Cell Carcinoma
A Phase 1 study, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT03467789: Completed Phase 1 study, sponsored by Case Comprehensive Cancer Center.
NCT03467789 is a Phase 1 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03467789, a Phase 1 study, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
The purpose of this study is to study 50 patients with multiple Basal Cell Carcinoma (BCC) who will be receiving Photodynamic Therapy (PDT) as treatment for their tumors. This study wants to establish the optimal conditions for treating BCC tumors with PDT. Previous research suggests that taking Vitamin D prior to the start of PDT could help improve the effectiveness of the treatment in eliminating the BCC. Overall, this study will help establish oral Vitamin D3/PDT as a new combination therapy for skin cancer (BCC). Photodynamic Therapy (PDT) is an investigational (experimental) technique that works by combining a photosensitizing topical agent and an intense light source to kill tumor cells. PDT is currently approved for the treatment of BCC in Europe, Canada, and Australia. However, it is experimental in the United States because it is not approved by the Food and Drug Administration (FDA).
Primary Outcome
Change in tumor diameter per month. For each participant, the investigators will analyze the difference in tumor clearance between treatments, one with neoadjuvant D3+PDT, the other with PDT alone, and the other with or without D3 in order to establish a D3 replete state. The order of the first two treatments is randomized in case the assumption of a linear tumor clearance rate is incorrect The statistical significance of the difference in Delta-T after D3+PDT versus the difference in Delta-T a
Interventions
- DRUG Dietary Vitamin D3 pre-treatment
- RADIATION Photodynamic therapy
- DRUG Serum Maintenance Vitamin D3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2023-01-06 |
| Phase | Phase 1 |
What the finished NCT03467789 record still lists
NCT03467789 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 3 interventions - of which Dietary Vitamin D3 pre-treatment is the first listed.
NCT03467789 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03467789 about?
NCT03467789 is a clinical study titled "Vitamin D as a Nutritional Neoadjuvant During Photodynamic Therapy of Basal Cell Carcinoma". The purpose of this study is to study 50 patients with multiple Basal Cell Carcinoma (BCC) who will be receiving Photodynamic Therapy (PDT) as treatment for their tumors. This study wants to establish the optimal conditions for treating BCC tumors with PDT. Previous research suggests that taking Vit...
What is the current status of trial NCT03467789?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2018-10-01. Estimated completion is 2023-01-06.
What interventions are being tested in trial NCT03467789?
The interventions under investigation include: Dietary Vitamin D3 pre-treatment (DRUG), Photodynamic therapy (RADIATION), Serum Maintenance Vitamin D3 (DRUG).
Who is sponsoring clinical trial NCT03467789?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03467789's enrollment target sits among peer trials
37 1204th of 2000 higher than 791 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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