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Trial Title:
Evaluating the Effects of Cannabis Use and Circulating Cannabinoids on Tumor Infiltrating Lymphocytes in Malignant Melanoma
NCT ID:
NCT05520294
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
High-performance liquid chromatography-tandem mass spectrometry assays
Description:
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
Arm group label:
Chronic Cannabinoid Users
Arm group label:
Non-users
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.
Criteria for eligibility:
Study pop:
Description of Population to be Enrolled:
Patients who are either chronic cannabis/cannabinoid users (use >1 time/week for >3
months of any cannabinoid product, with ingestion via edibles, smoking, or vaping) and
non-users for the last year who are scheduled to be seen in a clinic at the University of
Colorado Cancer Center will be approached for enrollment and informed consent. Enrollment
will be limited to stage Ib and II to decrease patient heterogeneity and since higher TIL
grade has been associated with earlier stage melanomas13, thus maximizing the potential
to observe an effect. Biopsy specimens must be obtained within 4 weeks of study
enrollment to ensure blood specimens are reflective of when biopsy specimens were
obtained.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
21 Years
Maximum age:
100 Years
Locations:
Facility:
Name:
University of Colorado Denver
Address:
City:
Aurora
Zip:
80045
Country:
United States
Start date:
September 1, 2022
Completion date:
August 31, 2024
Lead sponsor:
Agency:
University of Colorado, Denver
Agency class:
Other
Collaborator:
Agency:
Cancer League of Colorado
Agency class:
Other
Source:
University of Colorado, Denver
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05520294