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NCT06157099 · ClinicalTrials.gov registry record · Phase 2
Atorvastatin for Preventing Disease Metastasis in Patients With Resected High-Risk Stage IIA, IIB, or IIIA Melanoma
A Phase 2 study of Pathologic Stage IIIA Cutaneous Melanoma AJCC v8 and Pathologic Stage IIA Cutaneous Melanoma AJCC v8, sponsored by OHSU Knight Cancer Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT06157099 is a Phase 2 study of Pathologic Stage IIIA Cutaneous Melanoma AJCC v8 and Pathologic Stage IIA Cutaneous Melanoma AJCC v8 that is active but no longer recruiting, run by OHSU Knight Cancer Institute. The registered enrollment target is 150 participants, above the 80-participant average among 3 other Pathologic Stage IIIA Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (88% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06157099, a Phase 2 study of Pathologic Stage IIIA Cutaneous Melanoma AJCC v8 and Pathologic Stage IIA Cutaneous Melanoma AJCC v8, is active but no longer recruiting, sponsored by OHSU Knight Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
This clinical trial tests whether atorvastatin prevents metastasis of resected high-risk stage IIA, IIB or IIIA melanoma. The vast majority of melanomas are diagnosed at an early, localized stage. However, approximately 10-15% of these localized melanomas will eventually metastasize, despite appropriate local treatment. Once metastasis occurs, median survival is less than two years. Melanomas at high risk of metastasis can be identified by gene expression profiling. Statin drugs, like atorvastatin, have been used to treat high cholesterol for the prevention of major adverse cardiovascular events, but not for preventing melanoma metastasis. Statins could prevent melanoma metastasis through decreasing tumor cell migration, decreasing tumor cell adhesion, and increasing immune system response. Statins are also efficient inhibitors of new lymphatic vessels formation. Since tumor lymphatic vessels serve as highways to lymph nodes and may suppress immune system responses, statins may block a critical step towards melanoma metastasis. Using atorvastatin may have the potential to prevent metastasis and improve outcomes in patients with resected high-risk melanoma.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- OTHER Electronic Health Record Review
- DRUG Placebo Administration
- DRUG Atorvastatin
Study Locations (1)
Oregon
- OHSU Knight Cancer Institute - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-09-01 |
| Est. Completion | 2029-09-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06157099
The ClinicalTrials.gov registry entry for NCT06157099 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 80-participant average among 3 other Pathologic Stage IIIA Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (88% higher). The listed sponsor is OHSU Knight Cancer Institute, which has 211 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Pathologic Stage IIIA Cutaneous Melanoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT06157099 reports 1 study location spanning 1 distinct geographic area - top geographies include Oregon.
Frequently Asked Questions
What is clinical trial NCT06157099 about?
NCT06157099 is a clinical study titled "Atorvastatin for Preventing Disease Metastasis in Patients With Resected High-Risk Stage IIA, IIB, or IIIA Melanoma". This clinical trial tests whether atorvastatin prevents metastasis of resected high-risk stage IIA, IIB or IIIA melanoma. The vast majority of melanomas are diagnosed at an early, localized stage. However, approximately 10-15% of these localized melanomas will eventually metastasize, despite appropr...
What is the current status of trial NCT06157099?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2024-09-01. Estimated completion is 2029-09-01.
What conditions does trial NCT06157099 study?
This clinical trial studies the following conditions: Pathologic Stage IIIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIB Cutaneous Melanoma AJCC v8.
What interventions are being tested in trial NCT06157099?
The interventions under investigation include: Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Electronic Health Record Review (OTHER), Placebo Administration (DRUG), Atorvastatin (DRUG).
Who is sponsoring clinical trial NCT06157099?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06157099 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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