Clinical trial · Observational
Evaluating the Effects of Cannabis Use and Circulating Cannabinoids on Tumor Infiltrating Lymphocytes in Malignant Melanoma
NCT05520294CI-TRIAL-00076135unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this proposal is to determine how cannabinoid use affects the tumor immune microenvironment (TME) of melanoma by correlating TILs with reported cannabinoid use and circulating plasma cannabinoids. The central hypothesis is that cannabinoid use decreases TILs in melanoma in a dose-dependent fashion. This is important because cannabinoid-driven TME changes in melanoma may alter patient outcomes mediated by TILs and response to standard of care ICI treatments.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-performance liquid chromatography-tandem mass spectrometry assays | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Chronic Cannabinoid Users
- description
- Ib or II Melanoma patients who are chronic cannabinoid users
- interventionNames
- Other: High-performance liquid chromatography-tandem mass spectrometry assays
- label
- Non-users
- description
- Ib or II Melanoma patients non cannabinoid users
- interventionNames
- Other: High-performance liquid chromatography-tandem mass spectrometry assays
Primary outcomes (2)
- measure
- Grade of TIL in melanoma biopsy
- timeFrame
- 24 Months
- description
- Hematoxylin and eosin slide assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven melanoma, any stage * Biopsy obtained within 4 weeks of anticipated enrollment * Patients \>21 years old * Report no cannabis use in the last year or chronic cannabis use (at least weekly use for 3 months or more) Exclusion Criteria: * Patients unwilling or unable to provide informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.