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 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT04385732
Eligibility Criteria:
Inclusion criteria
Patients may be included in the study if they meet ALL of the following criteria:
1. Aged 18 years or older at date of diagnosis
2. Within 24 months (2 years) of the date of diagnosis when attending Screening \& Baseline Visit: where date of diagnosis refers to the date on the pathology report that provides histological confirmation of primary cutaneous melanoma (insitu or invasive)
3. Able to provide informed consent, complete questionnaires, and attend trial site for MSP\*
4. Appropriate for TBP referral
5. High/very high risk of subsequent primary melanoma (see risk assessment tool, Appendix IV)\*
6. Multiple naevi, as "some" or "many" naevi on pictogram below at Screening \& Baseline visit.
7. Not previously under active surveillance (at least yearly) with TBP for melanoma surveillance (see inclusion criteria 9)
8. Living in Australia and not planning to move overseas within the next 3 years
9. Participants that meet all eligibility criteria but have previously been under active surveillance with TBP for at least the previous 2 years meet exclusion critierion 1, in which case they are ineligible for the main study and eligible for sub-study 1 only.
Active surveillance with TBP refers to TBP images having been taken AND used for melanoma surveillance. As such, if a patient had TBP but these images were not used for melanoma surveillance (i.e. not used by clinicians to monitor a patient's skin), then surveillance is not considered active and the patient would still be eligible for the main study (as well as sub-study 1).
10. Patients need to have had at least annual surveillance over the past 2 years (at least) to be eligible for sub-study 1 (note that this refers to annual skin surveillance not annual TBP images being taken) (i.e. do not meet inclusion criteria 7 are eligible for sub-study 1)
Exclusion criteria
Patients will be excluded from the study for ANY of the following reasons:
1. Previously under active surveillance with TBP (active surveillance referring to TBP images being used for melanoma surveillance Stage IV metastatic melanoma
2. Stage IV metastatic melanoma
3. Ocular melanoma, mucosal melanoma
4. Participation in another clinical trial or study involving MSP
Note:
A past history of other cancers is not an exclusion criteria.
\*These eligibility criteria cannot be assessed by the cancer registry. These criteria will be assessed by the study team and/or referring doctor.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04385732
Study Brief:
Protocol Section:
NCT04385732