Non-melanoma Skin Cancer (NMSC)NCT02941900
Interest and Impact of Skin Cancer Genetic Testing
An observational study of Non-melanoma Skin Cancer (NMSC), run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to learn whether the patient might be interested in skin cancer genetic testing, and if so, what kinds of thoughts, feelings, and behaviors might result from this testing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-melanoma Skin Cancer (NMSC)
- What is being tested?
- MC1R genotyping, MC1R Testing Website and Baseline Survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 18 Jan 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MSK clinics
Who may be able to join
- 18 years of age or older
- English fluent as we do not have the resources to translate all the materials including the website and risk feedback materials into other languages
- Prior history of stage 0, I or II NMSC as per EMR or clinical judgment
Who cannot join
- Inability to provide meaningful informed consent due to cognitive or psychiatric disability as determined by the judgement of the consenting professional or clinician
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: PERSONALIZED GENOMIC TESTING FOR MELANOMA: MAXIMIZING COMPREHENSION AND HEALTH OUTCOMES IN SKIN CANCER PATIENTS
The purpose of this study is to learn whether the patient might be interested in skin cancer genetic testing, and if so, what kinds of thoughts, feelings, and behaviors might result from this testing. Testing for skin cancer risk based on the MC1R gene is not currently used in clinical practice; it will be offered in this study for research purposes only.
- Conditions
- Non-melanoma Skin Cancer (NMSC)
- Being tested
- MC1R genotyping, MC1R Testing Website, Baseline Survey
- Keywords
- Genetic Testing, 16-1243
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MC1R genotypingGenetic
MC1R Testing WebsiteBehavioural
The website includes three educational modules about genetic testing with corresponding knowledge questions.
Baseline SurveyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Non-melanoma skin cancers (NMSCs) | Not described Receives: Genetic: MC1R genotyping; Behavioral: MC1R Testing Website; Behavioral: Baseline Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients interested in MC1R testing
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startAug 2016
- Primary completion18 Jan 2023
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-melanoma Skin Cancer (NMSC)Studies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Hay, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941900
- Sponsor's protocol ID
- 16-1243
- Status last verified
- Jan 2023
- First submitted
- 20 Oct 2016
- Last updated
- 20 Jan 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERSONALIZED GENOMIC TESTING FOR MELANOMA: MAXIMIZING COMPREHENSION AND HEALTH OUTCOMES IN SKIN CANCER PATIENTS
- ClinicalTrials.gov ID
- NCT02941900
- Acronym / sponsor ID
- 16-1243
- Conditions
- Non-melanoma Skin Cancer (NMSC)
- Keywords
- Genetic Testing, 16-1243
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 21 Oct 2016 (estimated)
- 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 purpose of this study is to learn whether the patient might be interested in skin cancer genetic testing, and if so, what kinds of thoughts, feelings, and behaviors might result from this testing. Testing for skin cancer risk based on the MC1R gene is not currently used in clinical practice; it will be offered in this study for research purposes only.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-melanoma skin cancers (NMSCs) | – | Genetic: MC1R genotyping, Behavioral: MC1R Testing Website, Behavioral: Baseline Survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MSK clinics
Key inclusion criteria (3 listed)
- 18 years of age or older
- English fluent as we do not have the resources to translate all the materials including the website and risk feedback materials into other languages
- Prior history of stage 0, I or II NMSC as per EMR or clinical judgment
Key exclusion criteria (1 listed)
- Inability to provide meaningful informed consent due to cognitive or psychiatric disability as determined by the judgement of the consenting professional or clinician
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 |
|---|---|---|
| MC1R genotyping | Genetic | Non-melanoma skin cancers (NMSCs) |
| MC1R Testing WebsiteThe website includes three educational modules about genetic testing with corresponding knowledge questions. | Behavioural | Non-melanoma skin cancers (NMSCs) |
| Baseline Survey | Behavioural | Non-melanoma skin cancers (NMSCs) |
Primary outcome
number of patients interested in MC1R testing
Time frame: 1 year
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 20 Jan 2023.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Jennifer Hay, PhD principal investigator
Memorial Sloan Kettering Cancer Center
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 Non-melanoma Skin Cancer (NMSC), run by Memorial Sloan Kettering Cancer Center 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 3 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 20 Jan 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?
number of patients interested in MC1R testing (time frame: 1 year). 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 20 Jan 2023.