Phase
Condition
Surgery
Melanoma
Treatment
Wise vs wide
No Surgery
Surgery
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients need to fulfill all criteria listed below:
- Has recently been diagnosed with a primary invasive cutaneous melanoma of Breslowthickness ≤1.0 mm (pT1) as determined by a diagnostic excision with subsequenthistopathological analysis that:
Is located on a body location in which a WLE with a 10-mm clinical margin isfeasible 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 andfollow-up plan.
Has a life expectancy of ≥5 years from the time of diagnosis.
Exclusion
Exclusion Criteria:
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 acrallentiginous) 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 duringthe past 5 years except cutaneous squamous cell carcinoma or basal cell carcinoma.
has planned adjuvant radiotherapy to the primary melanoma site after WLE.
Study Design
Study Description
Connect with a study center
Sahlgrenska University Hospital
Gothenburg, 41345
SwedenActive - Recruiting
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