Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-24 @ 6:58 PM
NCT ID:
NCT02854657
Eligibility Criteria:
Inclusion Criteria:
* Personal history of Stage 0 (in situ) to IIB melanoma
* At least 6 weeks post-surgical treatment of Stage 0 (in situ) to IIB melanoma
* Age 18-70 years old
* Have sufficient vision to read a newspaper in order to visually detect changes of the skin
* Able to read English or Spanish at a sixth grade language level
* Have a skin check partner (i.e. spouse, family member, or friend) who is willing to participate in the research with the patient
Exclusion Criteria:
* Subjects overburdened with other co-morbid diseases (e.g. chronic immunosuppression from organ transplantation) or medical treatments (e.g. chemotherapy)
* Subjects unable to participate in a conversation at a sixth grade language level due to cognitive impairment (e.g. by a stroke)
* For newly enrolled subjects only: Prior participation in skin self-examination research
Eligibility Criteria for amended portion of the study:
Inclusion Criteria Melanoma survivors
* Ages 18-70, who are participating in the research supported by the R01
* Able to read English at a sixth-grade language level
* Willing to participate in daily online assessments
* Willingness to wear two sensors for 7 consecutive days
* Own a smartphone and able to use a mobile application
* Reliable access to the Internet
* Reliable mailing address for safe delivery and return of sensors
* Capable of walking a quarter of a mile (about 3 city blocks) with little to no difficulty
Young adult relatives of melanoma survivors
* Ages 18-39 years old
* Able to read English at a sixth-grade language level
* Willing to participate in daily online assessments
* Willing to wear two sensors for 7 consecutive days
* Own a smartphone and able to use a mobile application
* Reliable access to the Internet
* Reliable mailing address for safe delivery and return of sensors
* Capable of walking a quarter of a mile (about 3 city blocks) with little to no difficulty
Exclusion Criteria
* Excluded subjects are those overburdened with other co-morbid diseases (e.g. chronic immunosuppression from organ transplantation) or medical treatments (e.g. chemotherapy).
* Subjects unable to participate in a conversation at a sixth-grade language level due to cognitive impairment (e.g. by a stroke) and have an ECOG performance status \>1 will also be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02854657
Study Brief:
Protocol Section:
NCT02854657