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NCT04799106 Clinical Trial

Community Based Strategies for Early Detection of Melanoma

Melanoma Clinical Trial

Official title:
A Pilot Feasibility Study of Community Based Strategies for Early Detection of Melanoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04799106
Other study ID # STUDY00001181
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date March 1, 2025

Study information
Verified date August 2023
Source Cedars-Sinai Medical Center
Contact Hayden Hutchison, MSW, MPH
Phone 310-423-2361
Email hayden.hutchison@cshs.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to pilot the use of community education and digital dermatology to increase the early detection of curable melanomas.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date March 1, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Community Based Strategies for Early Detection of Melanoma
The main procedures of this study include educational sessions about melanoma and how to detect it at its earliest stages with the help of a community health worker, conducting a self-skin examination every three months, helping to perform a skin examination every three months for a family member or friend who would be selected as a "partner", and completing short questionnaires at the beginning of the study, at month three during the study, and at completion of the study.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Cedars-Sinai Medical Center Stanford University

Outcome
Type Measure Description Time frame Safety issue
Primary Completion of self and partner skin examinations Proportion of individuals recruited to those that follow through with the protocol 3 months
Primary Completion of self and partner skin examinations Proportion of individuals recruited to those that follow through with the protocol 6 months
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