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

NCT05520294 | Active Not Recruiting

• 1 other identifier: 22-1132
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (2)

• Grade of TIL in melanoma biopsy

  Hematoxylin and eosin slide assessment

  24 Months

• Composition of TILs within melanoma biopsy specimens

  Stains for TIL markers such as CD3, CD4, CD8, CD20, CD45RO, and FoxP3; T cell function IHC stains include: TOX, PD1, TIGIT, LAG3; melanoma specific marker SOX10

  24 Months

Study Arms (2)

Chronic Cannabinoid Users

Ib or II Melanoma patients who are chronic cannabinoid users

Other: High-performance liquid chromatography-tandem mass spectrometry assays

Non-users

Ib or II Melanoma patients non cannabinoid users

Other: High-performance liquid chromatography-tandem mass spectrometry assays

Interventions

High-performance liquid chromatography-tandem mass spectrometry assays OTHER

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

Chronic Cannabinoid Users; Non-users

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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)

You may not qualify if:

• Patients unwilling or unable to provide informed consent

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Cancer League of Colorado: collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Paraffin Tissue Blocks Whole Blood

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Camille Stewart, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 29, 2022
• Study Start: September 1, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

US (1)