A new method for monitoring melanoma patients
Official title: The MELAcare Study: a Randomized Controlled Trial of a New Method for Surveillance of Melanoma Patients
Run by Herlev and Gentofte Hospital · NCT05253872 · Data updated 2026-11-12
This study tests a new way to support and educate patients with low to intermediate risk melanoma to see if it helps them feel less anxious about cancer coming back and encourages them to check their skin regularly.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 378 (estimated) |
| Sponsor | Herlev and Gentofte Hospital Academic / other |
| Locations | 1 site (Copenhagen) |
| Status | Recruiting |
| Started | March 9, 2022 |
| Main results expected | June 2024 |
| Study ends | March 2028 |
| Registry record updated | June 26, 2023 |
| Trial ID | NCT05253872 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with clinical stage IA-IIA melanoma who can read and understand Danish and are willing to provide informed consent.
✕Probably not a fit
Patients with advanced melanoma or those at high risk for new primary melanomas will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates a novel follow-up approach for patients with low and intermediate risk melanoma (stages IA-IIA). It compares various patient support and education tools, along with clinician-supported skin self-examination (SSE), against the current standard care. The goal is to reduce fear of cancer recurrence and encourage regular SSE without compromising the detection of new melanomas or metastases.
Why it matters
Potential benefit: If successful, this approach could enhance patient self-management and reduce anxiety related to cancer recurrence.
How similar studies have gone: Other studies have shown promise in using self-examination and supportive strategies for cancer follow-up, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Herlev and Gentofte Hospital
Copenhagen, Denmark Recruiting
Study contacts
- Study coordinator: Sara M Hansen, MD
- Email: sara.moelgaard.hansen@regionh.dk
- Phone: +4538681296
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This Phase 1 study will try the experimental antibody-drug conjugate PF-08046033 in adults whose non-small-cell lung cancer, esophageal squamous cell cancer, or cutaneous melanoma has progressed after standard treatments.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.