NCT05520294

Evaluating the Effects of Cannabis Use and Circulating Cannabinoids on Tumor Infiltrating Lymphocytes in Malignant Melanoma

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 21 Years – 100 Years
• Healthy volunteers: —

Summary

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.

Detailed description

Specific Aim 1.Assess how systemic cannabinoids remodel tumor infiltrating lymphocytes (TILs) within the melanoma tumor microenvironment. We hypothesize that decreased grade of TILs and exhaustive differentiation of T cells in melanoma are associated with lower cannabinoid receptor (CB1/CB2) expression and higher levels of systemic exogenous cannabinoids. Aim 1a.) Correlate plasma levels of cannabinoids with TIL grade. Aim 1b.) Correlate plasma levels of cannabinoids with TIL T cell immunohistochemical markers of exhaustion. Aim 1c.) Correlate plasma levels of cannabinoids to TIL CB1/CB2 expression. Specific Aim 2. Determine the relationship between peripheral T cell activation and circulating cannabinoid levels in patients with melanoma. We hypothesize that the phenotypic activation of peripheral T cells is inversely associated with increased plasma levels of systemic exogenous cannabinoids. Aim 2a.) Immunophenotype peripheral T cells from patients with melanoma. Aim 2b.) Correlate plasma levels of cannabinoids with peripheral T cell phenotypic activation.

Conditions

• Melanoma

Interventions

Type	Name	Description
OTHER	High-performance liquid chromatography-tandem mass spectrometry assays	Paraffin blocks will be requested for slide creation, and at least 12 mL of whole blood will be collected in 2 green top tubes, centrifuged, and plasma transferred for storage at -80 C until further processing

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2022-08-29
• Last updated: 2024-04-17

Locations

1 site across 1 country: United States