Nevi and MelanomasNCT03783325
Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma
A study testing UV Counseling, UV Photo and Biological Sample in people with Nevi and Melanomas, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This research study is designed to better understand the role of genetics, sun-exposure and phenotypic factors in melanoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nevi and Melanomas
- What is being tested?
- UV Counseling, UV Photo and Biological Sample
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2017to 17 Jun 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > or = 18 years of age
- Patient at the University of Colorado Anschutz Medical Campus Cutaneous Oncology Clinic or Dermatology Clinic OR attend the fundraising event of the Colorado Melanoma Foundation
Who cannot join
- 1. No exclusion criteria listed
Trial locations and contacts
1 site in 1 country.
About this study
This research study is designed to better understand the role of genetics, sun-exposure and phenotypic factors in melanoma.
- Conditions
- Nevi and Melanomas
- Being tested
- UV Counseling, UV Photo, Biological Sample
- Keywords
- Sun Exposure, UV Dosimetry, Biomarkers, Behaviors, Genetics
- Medical subject headings
- Nevi and Melanomas, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UV CounselingBehavioural
This is a sub-study that involves a behavioral intervention. Participants will wear a UV dosimetry for 3 weeks, return the device and receive feedback. After the feedback, they will re-wear the device for an additional 3 weeks.
UV PhotoOther
Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team.
Biological SampleOther
Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team.
| Study group | Role | What they receive |
|---|---|---|
| UV Counseling | Other | Evaluate the effectiveness of dosimetry feedback on sun exposure behaviors, attitudes, and awareness in patients diagnosed with melanoma. Receives: Behavioral: UV Counseling |
| Visual Analysis - UV Photo | Experimental | Assess the relationships between UV camera score, silicone mold of a skin patch, phenotypic evaluation and sun-exposure behaviors. Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team. Receives: Other: UV Photo |
| Biological Sample | Experimental | Determine the relationship between measures of sun exposure and genomic characteristics of tumors in melanoma patients. Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team. Receives: Other: Biological Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sun Exposure Behaviors
A short questionnaire is administered during the clinic visit to assess sun exposure behaviors of melanoma patients. The data gathered from this questionnaire will help identify possible trends in sun exposure behaviors and provide a baseline dataset for future research,
Measured: Start of study, initial interaction with participants.
UV Exposure Assessment
Identify the difference between self-reported sun exposure behavior and actual UV exposure by having patients wear individual dosimeters
Measured: Start of study to end of study, up to 6 weeks
Visual Appearance Relationships: Melanoma, Questionnaire
Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a sun exposure questionnaire
Measured: Start of study to end of study, up to 3 years
Visual Appearance Relationships: Non-Melanoma , Questionnaire
Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a sun exposure questionnaire
Measured: Start of study to end of study, up to 3 years
Visual Appearance Relationships: Melanoma, Photography
Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a UV photography
Measured: Start of study to end of study, up to 3 years
Visual Appearance Relationships: Non-Melanoma, Photography
Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a UV photography
Measured: Start of study to end of study, up to 3 years
Visual Appearance Relationships: Melanoma, Casting
Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a silicone casts
Measured: Start of study to end of study, up to 3 years
Visual Appearance Relationships: Non-Melanoma, Casting
Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a silicone casts
Measured: Start of study to end of study, up to 3 years
Visual Appearance Relationships: Melanoma, SCINEXA
Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a SCINEXA exam.
Measured: Start of study to end of study, up to 3 years
Visual Appearance Relationships: Non-Melanoma, SCINEXA
Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a SCINEXA exam.
Measured: Start of study to end of study, up to 3 years
Genetics Correlations
Determine whether UV exposure and camera scores correlates with UV signature (somatic) mutations and other tumor-related mutations in clinically benign nevi and primary melanomas using saliva samples, benign nevi, and primary melanomas. Next Generation Sequencing (NGS) will be used to obtain the genetic information from all samples.
Measured: Start of study to end of study, up to 3 years
Secondary outcomes (10)
Self Reporting Behaviors
Determine self-reported sun exposure behaviors through participant interviews. Questions are related to time spent outside, and what attempts to be sun-safe occurred while outside.
Measured: Start of study to end of study, up to 3 years
Behavioral Intervention and Immediate Follow Up
Participants will receive a personalized feedback plan and the success of the plan will be measured through individual dosimetry. We will track real time change in sun exposure based on repeat UV dosimetry.
Measured: After wearing dosimetry for 3 weeks
Benign Nevi, DNA
Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of genomic DNA
Measured: Start of study to end of study, up to 3 years
Benign Nevi, Mutations
Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of somatic mutations
Measured: Start of study to end of study, up to 3 years
Benign Nevi, Exposure
Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of analysis of UV exposure history
Measured: Start of study to end of study, up to 3 years
Benign Nevi, UV Camera
Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of analysis of UV camera scores with the clinical presentation
Measured: Start of study to end of study, up to 3 years
Primary Melanomas, DNA
Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of genomic DNA
Measured: Start of study to end of study, up to 3 years
Primary Melanomas, Mutations
Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of somatic mutations
Measured: Start of study to end of study, up to 3 years
Primary Melanomas, Exposure
Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of UV exposure history
Measured: Start of study to end of study, up to 3 years
Primary Melanomas, UV Camera
Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of UV camera scores with the clinical presentation
Measured: Start of study to end of study, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start17 Feb 2017
- Primary completion17 Jun 2022
- Study completion17 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nevi and MelanomasStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Patients will have the opportunity to participate in a questionnaire and then they are given the option to participate in substudy A (wear a UV dosimeter, complete questionnaires, and receive feedback based on the UV dosimeter results), subtstudy B (wear a skin patch, participate in a UV photo analysis, answer questionnaires), and/or substudy C (give biological samples via nevi).
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil Box, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783325
- Sponsor's protocol ID
- 16-1603.cc
- Status last verified
- Oct 2023
- First submitted
- 13 Dec 2018
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma
- ClinicalTrials.gov ID
- NCT03783325
- Acronym / sponsor ID
- 16-1603.cc
- Conditions
- Nevi and Melanomas
- Keywords
- Sun Exposure, UV Dosimetry, Biomarkers, Behaviors, Genetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 21 Dec 2018 (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.
This research study is designed to better understand the role of genetics, sun-exposure and phenotypic factors in melanoma.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients will have the opportunity to participate in a questionnaire and then they are given the option to participate in substudy A (wear a UV dosimeter, complete questionnaires, and receive feedback based on the UV dosimeter results), subtstudy B (wear a skin patch, participate in a UV photo analysis, answer questionnaires), and/or substudy C (give biological samples via nevi).
| Arm | Type | Receives |
|---|---|---|
| UV Counseling | Other | Behavioral: UV CounselingEvaluate the effectiveness of dosimetry feedback on sun exposure behaviors, attitudes, and awareness in patients diagnosed with melanoma. |
| Visual Analysis - UV Photo | Experimental | Other: UV PhotoAssess the relationships between UV camera score, silicone mold of a skin patch, phenotypic evaluation and sun-exposure behaviors. Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team. |
| Biological Sample | Experimental | Other: Biological SampleDetermine the relationship between measures of sun exposure and genomic characteristics of tumors in melanoma patients. Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- > or = 18 years of age
- Patient at the University of Colorado Anschutz Medical Campus Cutaneous Oncology Clinic or Dermatology Clinic OR attend the fundraising event of the Colorado Melanoma Foundation
Key exclusion criteria (1 listed)
- 1. No exclusion criteria listed
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 |
|---|---|---|
| UV CounselingThis is a sub-study that involves a behavioral intervention. Participants will wear a UV dosimetry for 3 weeks, return the device and receive feedback. After the feedback, they will re-wear the device for an additional 3 weeks. | Behavioural | UV Counseling |
| UV PhotoTechnically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team. | Other | Visual Analysis - UV Photo |
| Biological SampleTechnically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team. | Other | Biological Sample |
Primary outcome
Sun Exposure Behaviors
Time frame: Start of study, initial interaction with participants.
A short questionnaire is administered during the clinic visit to assess sun exposure behaviors of melanoma patients. The data gathered from this questionnaire will help identify possible trends in sun exposure behaviors and provide a baseline dataset for future research,
UV Exposure Assessment
Time frame: Start of study to end of study, up to 6 weeks
Identify the difference between self-reported sun exposure behavior and actual UV exposure by having patients wear individual dosimeters
Visual Appearance Relationships: Melanoma, Questionnaire
Time frame: Start of study to end of study, up to 3 years
Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a sun exposure questionnaire
Visual Appearance Relationships: Non-Melanoma , Questionnaire
Time frame: Start of study to end of study, up to 3 years
Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a sun exposure questionnaire
Visual Appearance Relationships: Melanoma, Photography
Time frame: Start of study to end of study, up to 3 years
Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a UV photography
Visual Appearance Relationships: Non-Melanoma, Photography
Time frame: Start of study to end of study, up to 3 years
Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a UV photography
Visual Appearance Relationships: Melanoma, Casting
Time frame: Start of study to end of study, up to 3 years
Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a silicone casts
Visual Appearance Relationships: Non-Melanoma, Casting
Time frame: Start of study to end of study, up to 3 years
Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a silicone casts
Visual Appearance Relationships: Melanoma, SCINEXA
Time frame: Start of study to end of study, up to 3 years
Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a SCINEXA exam.
Visual Appearance Relationships: Non-Melanoma, SCINEXA
Time frame: Start of study to end of study, up to 3 years
Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a SCINEXA exam.
Genetics Correlations
Time frame: Start of study to end of study, up to 3 years
Determine whether UV exposure and camera scores correlates with UV signature (somatic) mutations and other tumor-related mutations in clinically benign nevi and primary melanomas using saliva samples, benign nevi, and primary melanomas. Next Generation Sequencing (NGS) will be used to obtain the genetic information from all samples.
10 secondary outcomes
Self Reporting Behaviors
Time frame: Start of study to end of study, up to 3 years
Behavioral Intervention and Immediate Follow Up
Time frame: After wearing dosimetry for 3 weeks
Benign Nevi, DNA
Time frame: Start of study to end of study, up to 3 years
Benign Nevi, Mutations
Time frame: Start of study to end of study, up to 3 years
Benign Nevi, Exposure
Time frame: Start of study to end of study, up to 3 years
Benign Nevi, UV Camera
Time frame: Start of study to end of study, up to 3 years
Primary Melanomas, DNA
Time frame: Start of study to end of study, up to 3 years
Primary Melanomas, Mutations
Time frame: Start of study to end of study, up to 3 years
Primary Melanomas, Exposure
Time frame: Start of study to end of study, up to 3 years
Primary Melanomas, UV Camera
Time frame: Start of study to end of study, up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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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.
Neil Box, PhD 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?
A study testing UV Counseling, UV Photo and Biological Sample in people with Nevi and Melanomas, 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 2 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: finished, as of the sponsor's last update on 23 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sun Exposure Behaviors (time frame: Start of study, initial interaction with participants.). The study lists 11 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 23 Oct 2023.