MelanomaNCT05520294
Evaluating the Effects of Cannabis Use and Circulating Cannabinoids on Tumor Infiltrating Lymphocytes in Malignant Melanoma
An observational study of Melanoma, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Melanoma
- What is being tested?
- High-performance liquid chromatography-tandem mass spectrometry assays
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Patients unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
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.
Read the 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
- Being tested
- High-performance liquid chromatography-tandem mass spectrometry assays
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-performance liquid chromatography-tandem mass spectrometry assaysOther
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
| Study group | Role | What they receive |
|---|---|---|
| Chronic Cannabinoid Users | Ib or II Melanoma patients who are chronic cannabinoid users Receives: Other: High-performance liquid chromatography-tandem mass spectrometry assays | |
| Non-users | Ib or II Melanoma patients non cannabinoid users Receives: Other: High-performance liquid chromatography-tandem mass spectrometry assays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of TIL in melanoma biopsy
Hematoxylin and eosin slide assessment
Measured: 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
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Sep 2022
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer League of Colorado
- Responsible party
- Sponsor
- Investigators
- Camille Stewart, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520294
- Sponsor's protocol ID
- 22-1132
- Status last verified
- Apr 2024
- First submitted
- 25 Aug 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Cannabis Use and Circulating Cannabinoids on Tumor Infiltrating Lymphocytes in Malignant Melanoma
- ClinicalTrials.gov ID
- NCT05520294
- Acronym / sponsor ID
- 22-1132
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Cancer League of Colorado
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Cannabinoid Users | – | Other: High-performance liquid chromatography-tandem mass spectrometry assaysIb or II Melanoma patients who are chronic cannabinoid users |
| Non-users | – | Other: High-performance liquid chromatography-tandem mass spectrometry assaysIb or II Melanoma patients non cannabinoid users |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Biopsy proven melanoma, any stage
Key exclusion criteria (1 listed)
- Patients unwilling or unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-performance liquid chromatography-tandem mass spectrometry assaysParaffin 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 | Other | Chronic Cannabinoid Users, Non-users |
Primary outcome
Grade of TIL in melanoma biopsy
Time frame: 24 Months
Hematoxylin and eosin slide assessment
Composition of TILs within melanoma biopsy specimens
Time frame: 24 Months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camille Stewart, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade of TIL in melanoma biopsy (time frame: 24 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.