NCT02941900

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2023

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

6.5 years

First QC Date

October 20, 2016

Last Update Submit

January 19, 2023

Conditions

Non-melanoma Skin Cancer (NMSC)

Keywords

Genetic Testing16-1243

Outcome Measures

Primary Outcomes (1)

  • number of patients interested in MC1R testing

    1 year

Study Arms (1)

Non-melanoma skin cancers (NMSCs)

Genetic: MC1R genotypingBehavioral: MC1R Testing WebsiteBehavioral: Baseline Survey

Interventions

MC1R genotypingGENETIC
Non-melanoma skin cancers (NMSCs)
MC1R Testing WebsiteBEHAVIORAL

The website includes three educational modules about genetic testing with corresponding knowledge questions.

Non-melanoma skin cancers (NMSCs)
Baseline SurveyBEHAVIORAL
Non-melanoma skin cancers (NMSCs)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MSK clinics

You may qualify if:

  • 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

You may not qualify if:

  • Inability to provide meaningful informed consent due to cognitive or psychiatric disability as determined by the judgement of the consenting professional or clinician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

saliva sample

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jennifer Hay, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 20, 2016

First Posted

October 21, 2016

Study Start

August 1, 2016

Primary Completion

January 18, 2023

Study Completion

January 18, 2023

Last Updated

January 20, 2023

Record last verified: 2023-01

Locations

US(1)