- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04799106
Community Based Strategies for Early Detection of Melanoma
August 28, 2023 updated by: Robert Haile, Cedars-Sinai Medical Center
A Pilot Feasibility Study of Community Based Strategies for Early Detection of Melanoma
The purpose of this study is to pilot the use of community education and digital dermatology to increase the early detection of curable melanomas.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hayden Hutchison, MSW, MPH
- Phone Number: 310-423-2361
- Email: hayden.hutchison@cshs.org
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
200 melanoma survivors drawn from the California Cancer Registry will be invited to participate in the study.
Assuming a 20% response rate, approximately 40 individuals will be identified to participate in the study, including 20 in Southern California and 20 in Northern California.
Participants will be invited to identify up to four friends or first-degree family members to also participate in the study, for a total of 200 participants.
Description
Inclusion Criteria:
- 18 years and older
- >1mm lesion thickness with ulceration (T2b) or >2mm lesion thickness (T3/T4)
- Low socioeconomic status (SES) Non-Latinx White individuals (according to Yost's index SES level based on a principal components analysis)
- Latinx individuals
- Individual resides in semi-rural area, including zip codes within Antelope Valley in Southern California and Salinas in Northern California
- Individual speaks and reads English or Spanish
- Voluntary willingness and comprehension to consent
Exclusion Criteria:
Exclusion criteria is stage 0, I, IV, or unstaged diagnosis, or any individual who does not meet the above stated eligibility criteria will be excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Completion of self and partner skin examinations
Time Frame: 3 months
|
Proportion of individuals recruited to those that follow through with the protocol
|
3 months
|
|
Completion of self and partner skin examinations
Time Frame: 6 months
|
Proportion of individuals recruited to those that follow through with the protocol
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Haile, DrPH, MPH, Cedars-Sinai
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2024
Primary Completion (Estimated)
January 31, 2025
Study Completion (Estimated)
March 1, 2025
Study Registration Dates
First Submitted
March 9, 2021
First Submitted That Met QC Criteria
March 11, 2021
First Posted (Actual)
March 16, 2021
Study Record Updates
Last Update Posted (Actual)
August 29, 2023
Last Update Submitted That Met QC Criteria
August 28, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00001181
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.