NCT06363591Recruiting
WoW - Single- vs Two-staged Excisions of Thin Melanoma
Wise vs Wide: A National, Multicenter, Prospective, Randomized and Controlled, Parallel Group, Non-inferiority Study to Compare Single- vs Two-staged Excisions of Thin Melanoma
Source: ClinicalTrials.gov · Last updated 5 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The overall aim of this national, multicenter, prospective, randomized, and controlled study is to enhance the management of patients with thin melanoma (≤1 mm Breslow thickness). The investigators hypothesize that wide local excisions (WLEs) following complete excision of thin melanoma do not affect the risk of recurrence, defined as the occurrence of local, regional, distant disease, or melanoma-specific death during a 5- to 10-year follow-up period.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2486 (estimated)
- First submitted
- 28 Mar 2024
- Start date
- Jan 2025
- Primary completion date
- Dec 2034
- Lead sponsor
- Vastra Gotaland Region
- Diseases
- Melanoma
- NCT number
- NCT06363591
What you commit to
- Study type: Interventional
- Planned participants: 2486
- From Jan 2025 to the primary completion date, Dec 2034
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- was partially biopsied prior to the diagnostic excision.
- had a previous or concurrent MIS or invasive melanoma (cutaneous or non-cutaneous).
- had a previous or intercurrent treated solid tumor or hematologic malignancy during the past 5 years except cutaneous squamous cell carcinoma or basal cell carcinoma.
- has planned adjuvant radiotherapy to the primary melanoma site after WLE.
Other
- If any of the listed criteria below are present, the patient is ineligible for study participation.
- The study lesion:
- was diagnostically excised with a clinical margin \>5 mm.
- was a melanoma of desmoplastic or lentiginous (i.e. lentigo maligna or acral lentiginous) subtype.
- was located on digits in which amputation is necessary.
- The patient:
- had physical, clinical, radiographic or pathologic evidence of microsatellite, satellite, in-transit, regional or distant metastatic melanoma.
Who the study is looking for
- Patients need to fulfill all criteria listed below:
- Has recently been diagnosed with a primary invasive cutaneous melanoma of Breslow thickness ≤1.0 mm (pT1) as determined by a diagnostic excision with subsequent histopathological analysis that:
- Is located on a body location in which a WLE with a 10-mm clinical margin is feasible and would have been planned according to current standard of care.
- Had histopathologically verified free margins of at least 1.5 mm.
- Is 18 years or older at time of consent.
- Is able to give informed consent and comply with the treatment protocol and follow-up plan.
- Has a life expectancy of ≥5 years from the time of diagnosis.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.