NCT05253872 The MELAcare Study: A New Method for Surveillance of Melanoma Patients
| NCT ID | NCT05253872 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Herlev and Gentofte Hospital |
| Condition | Cutaneous Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 378 participants |
| Start Date | 2022-03-09 |
| Primary Completion | 2024-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 378 participants in total. It began in 2022-03-09 with a primary completion date of 2024-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to evaluate a new method of follow-up for patients with low and intermediate risk (stages IA-IIA) melanoma. The investigators will compare different tools for patient support and education combined with clinician supported skin self-examination (SSE) to the current standard-of-care. The hypothesis is that meta-cognitive strategies and clinician supported SSE can lower fear of cancer recurrence (FCR) and promote effective SSE on a regular basis without compromising the detection of new primary melanomas and/or metastases.
Eligibility Criteria
Inclusion Criteria: * Ability to read and understand Danish language * Willing and able to give written informed consent * Surgical treatment of a clinical stage IA-IIA melanoma within 3 months of inclusion Exclusion Criteria: * Advanced melanoma, clinical stages IIB, IIC, III, or IV * Patients with high risk of a new primary melanoma (dysplastic nevus syndrome, or family history of melanoma) * History of melanoma skin cancer prior to the index diagnosis * Previous cancer, excluding non-melanoma skin cancer * Comorbidity that makes skin self-examination impossible (e.g. physical or mental disabilities, dementia or decreased cognitive function) * non-detection of sentinel node in IB and IIA patients
Contact & Investigator
Lisbet R Hölmich, Professor
STUDY CHAIR
Herlev and Gentofte Hospital
Frequently Asked Questions
Who can join the NCT05253872 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cutaneous Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05253872 currently recruiting?
Yes, NCT05253872 is actively recruiting participants. Contact the research team at sara.moelgaard.hansen@regionh.dk for enrollment information.
Where is the NCT05253872 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT05253872 clinical trial?
NCT05253872 is sponsored by Herlev and Gentofte Hospital. The principal investigator is Lisbet R Hölmich, Professor at Herlev and Gentofte Hospital. The trial plans to enroll 378 participants.
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