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

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

Cedars-Sinai Medical Center

Collaborators

Stanford University

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.

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