WoW - Single- vs Two-staged Excisions of Thin Melanoma
WoW
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
1 other identifier
interventional
2,486
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2024
CompletedFirst Posted
Study publicly available on registry
April 12, 2024
CompletedStudy Start
First participant enrolled
January 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2034
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2039
March 5, 2025
January 1, 2025
9.9 years
March 28, 2024
February 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence rate at 5 years.
Recurrence is defined as any presence of local/regional/distant disease or melanoma-specific death.
5 years
Secondary Outcomes (1)
Recurrence rate at 10 years.
10 years
Other Outcomes (13)
Postoperative complications
3 months
Scar length, width and quality
1 year
Scar length, width and quality
3 years
- +10 more other outcomes
Study Arms (2)
Wide - With wide local excision - Control group
OTHERStandard treatment with a wide local excision (i.e. reexcision of the diagnostic excision scar with a lateral clinical surgical margin of 10 mm and a deep clinical surgical margin down to the muscular fascia as recommended by the Swedish national guidelines).
Wise - Without wide local excision - Experimental group
EXPERIMENTALNo wide local excision.
Interventions
Eligibility Criteria
You may qualify 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 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.
You may not qualify 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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vastra Gotaland Regionlead
- Region Stockholmcollaborator
- Region Skanecollaborator
- Region Västerbottencollaborator
- Region Örebro Countycollaborator
- Blekinge County Council Hospitalcollaborator
- Region Östergötlandcollaborator
- Dalarna County Council, Swedencollaborator
Study Sites (1)
Sahlgrenska University Hospital
Gothenburg, 41345, Sweden
Related Publications (1)
Wennberg E, Claeson M, Olofsson Bagge R, Polesie S, Paoli J. Wise or wide (WoW) study protocol: a national, multicentre, prospective, randomised and controlled, parallel group, non-inferiority study to compare single-staged versus two-staged excisions of thin invasive (</=1.0 mm) melanoma. BMJ Open. 2025 Apr 2;15(4):e094544. doi: 10.1136/bmjopen-2024-094544.
PMID: 40180392DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Paoli, Professor
Dept. of Dermatology and Venereology, Sahlgrenska Academy, University of Gothenburg, Sweden
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2024
First Posted
April 12, 2024
Study Start
January 22, 2025
Primary Completion (Estimated)
December 31, 2034
Study Completion (Estimated)
December 31, 2039
Last Updated
March 5, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data will be available 6 months after publication of study results (start date) and 1 year after this (end date).
- Access Criteria
- Data will be shared upon reasonable request and accessed by contacting john.paoli@gu.se.
De-identified individual participant data will be shared upon reasonable request.