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Compares treatment options for Melanoma
Official title WoW - Single- vs Two-staged Excisions of Thin Melanoma
ClinicalTrials.gov ID: NCT06363591
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Had histopathologically verified free margins of at least 1.5 mm.
- Is 18 years or older at time of consent.
You likely can't join if
- If any of the listed criteria below are present, the patient is ineligible for study participation. The study lesion:
- was partially biopsied prior to the diagnostic excision.
- 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 a previous or concurrent MIS or invasive melanoma (cutaneous or non-cutaneous).
See the full eligibility criteria
- 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.
- If any of the listed criteria below are present, the patient is ineligible for study participation. The study lesion:
- was partially biopsied prior to the diagnostic excision.
- 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 a previous or concurrent MIS or invasive melanoma (cutaneous or non-cutaneous).
- had physical, clinical, radiographic or pathologic evidence of microsatellite, satellite, in-transit, regional or distant metastatic melanoma.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Gothenburg, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gothenburg, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.