MelanomaWoWNCT06363591
WoW - Single- vs Two-staged Excisions of Thin Melanoma
A study testing Surgery and No Surgery in people with Melanoma, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Surgery and No Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,486 participants
- Where
- 1 siteSweden
- Study dates
- 22 Jan 2025to 31 Dec 2039
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, 41345
John Paoli, Professor, +46730404044, john.paoli@vgregion.se
John Paoli, Professor
About this study
Official title: 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
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.
Read the detailed description
Melanoma is one of the most common forms of skin cancer and has become the third most common type of cancer among men and the fourth most common among women in Sweden.
The mortality associated with melanoma is strongly linked to the thickness of the original tumor. Thicker tumors generally have a worse prognosis compared to thinner tumors. In melanoma in situ (MIS), the tumor is confined to the epidermis and cannot spread. In invasive melanoma, the tumor has grown into the dermis. The thickness of these invasive melanomas is measured using the "Breslow thickness." Thinner invasive melanomas with a Breslow thickness of ≤1.0 mm constitute the majority of cases in Sweden and have an excellent prognosis with a 10-year disease-specific survival rate of 97%.
Melanoma represents a significant economic burden with increasing healthcare costs. Early detection and cost-effective treatment strategies are therefore important to improve prognosis, reduce costs, and avoid unnecessary overtreatment.
Surgical methods for treating melanoma vary depending on the thickness of the tumor. Traditionally, a two-step procedure has been used. Initially, a diagnostic excision (surgery to remove the tumor) with a narrow clinical margin is performed. Once melanoma is confirmed, a second wide local excision (WLE) is performed around the surgical scar with a 1-2 cm clinical margin depending on the exact Breslow thickness. This method has evolved over time, and narrower clinical margins are now used in the WLE than previously. However, researchers have begun to question whether a WLE is necessary at all for thin melanomas if the tumor is completely removed during the initial diagnostic excision.
Researchers are now exploring a more personalized treatment strategy that considers histopathological margins instead of a standardized clinical margin. For well-defined melanomas, a clinical margin of 3-5 mm may be sufficient to ensure that the melanoma is removed with an acceptable histopathological margin (≥1.5 mm). The hypothesis is that this margin may be adequate and that the WLE does not reduce the risk of local, regional or distant disease nor melanoma-specific death. If the hypothesis is proven, unnecessary surgery, patient suffering, risk of complications, resource utilization, and healthcare costs could be reduced.
The investigators now want to investigate whether there is a difference in the risk of recurrence, spread, and/or death for patients with thin melanomas (≤1mm Breslow thickness) treated with only one excision compared to the current standard of two excisions.
- Conditions
- Melanoma
- Being tested
- Surgery, No Surgery
- Keywords
- Melanoma, Surgery, Wide local excision, Recurrence, Metastasis, Death
- Medical subject headings
- Melanoma, Recurrence, Neoplasm Metastasis, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Wise or wide excision
No SurgeryOther
No wide local excision
| Study group | Role | What they receive |
|---|---|---|
| Wide - With wide local excision - Control group | Other | Standard 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). Receives: Procedure: Surgery |
| Wise - Without wide local excision - Experimental group | Experimental | No wide local excision. Receives: Other: No Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate at 5 years.
Recurrence is defined as any presence of local/regional/distant disease or melanoma-specific death.
Measured: 5 years
Secondary outcomes (1)
Recurrence rate at 10 years.
Recurrence is defined as any presence of local/regional/distant disease or melanoma-specific death.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start22 Jan 2025
- Primary completion31 Dec 2034 (estimated)
- Study completion31 Dec 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with thin (≤1.0 mm) invasive melanomas excised with a histopathological margin ≥1.5 mm will be offered to participate following informed consent and randomization (1:1) to either: 1. Standard treatment with a WLE 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. or 2. Experimental treatment with no WLE.
- Masking
- None (open label)
- Enrolment
- 2,486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Region Stockholm, Region Skane, Region Västerbotten, Region Örebro County, Blekinge County Council Hospital, Region Östergötland, Dalarna County Council, Sweden
- Responsible party
- Sponsor
- Investigators
- John Paoli, Professor, Principal investigator, Dept. of Dermatology and Venereology, Sahlgrenska Academy, University of Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363591
- Sponsor's protocol ID
- WoW - Wise or wide
- Acronym
- WoW
- Status last verified
- Jan 2025
- First submitted
- 28 Mar 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared upon reasonable request.
Publications
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.
PubMed 40180392
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06363591
- Acronym / sponsor ID
- WoW / WoW - Wise or wide
- Conditions
- Melanoma
- Keywords
- Melanoma, Surgery, Wide local excision, Recurrence, Metastasis, Death
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,486 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Region Stockholm, Region Skane, Region Västerbotten, Region Örebro County, Blekinge County Council Hospital, Region Östergötland, Dalarna County Council, Sweden
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 31 Dec 2034 (estimated)
- Study completion
- 31 Dec 2039 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Melanoma is one of the most common forms of skin cancer and has become the third most common type of cancer among men and the fourth most common among women in Sweden.
The mortality associated with melanoma is strongly linked to the thickness of the original tumor. Thicker tumors generally have a worse prognosis compared to thinner tumors. In melanoma in situ (MIS), the tumor is confined to the epidermis and cannot spread. In invasive melanoma, the tumor has grown into the dermis. The thickness of these invasive melanomas is measured using the "Breslow thickness." Thinner invasive melanomas with a Breslow thickness of ≤1.0 mm constitute the majority of cases in Sweden and have an excellent prognosis with a 10-year disease-specific survival rate of 97%.
Melanoma represents a significant economic burden with increasing healthcare costs. Early detection and cost-effective treatment strategies are therefore important to improve prognosis, reduce costs, and avoid unnecessary overtreatment.
Surgical methods for treating melanoma vary depending on the thickness of the tumor. Traditionally, a two-step procedure has been used. Initially, a diagnostic excision (surgery to remove the tumor) with a narrow clinical margin is performed. Once melanoma is confirmed, a second wide local excision (WLE) is performed around the surgical scar with a 1-2 cm clinical margin depending on the exact Breslow thickness. This method has evolved over time, and narrower clinical margins are now used in the WLE than previously. However, researchers have begun to question whether a WLE is necessary at all for thin melanomas if the tumor is completely removed during the initial diagnostic excision.
Researchers are now exploring a more personalized treatment strategy that considers histopathological margins instead of a standardized clinical margin. For well-defined melanomas, a clinical margin of 3-5 mm may be sufficient to ensure that the melanoma is removed with an acceptable histopathological margin (≥1.5 mm). The hypothesis is that this margin may be adequate and that the WLE does not reduce the risk of local, regional or distant disease nor melanoma-specific death. If the hypothesis is proven, unnecessary surgery, patient suffering, risk of complications, resource utilization, and healthcare costs could be reduced.
The investigators now want to investigate whether there is a difference in the risk of recurrence, spread, and/or death for patients with thin melanomas (≤1mm Breslow thickness) treated with only one excision compared to the current standard of two excisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with thin (≤1.0 mm) invasive melanomas excised with a histopathological margin ≥1.5 mm will be offered to participate following informed consent and randomization (1:1) to either: 1. Standard treatment with a WLE 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. or 2. Experimental treatment with no WLE.
| Arm | Type | Receives |
|---|---|---|
| Wide - With wide local excision - Control group | Other | Procedure: SurgeryStandard 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 | Experimental | Other: No SurgeryNo wide local excision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 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.
Key exclusion criteria (11 listed)
- If any of the listed criteria below are present, the patient is ineligible for study participation.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryWise or wide excision | Procedure or surgery | Wide - With wide local excision - Control group |
| No SurgeryNo wide local excision | Other | Wise - Without wide local excision - Experimental group |
Primary outcome
Recurrence rate at 5 years.
Time frame: 5 years
Recurrence is defined as any presence of local/regional/distant disease or melanoma-specific death.
1 secondary outcome
Recurrence rate at 10 years.
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Derived from this study: PubMed 40180392Wennberg 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Paoli, Professor principal investigator
Dept. of Dermatology and Venereology, Sahlgrenska Academy, University of Gothenburg, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery and No Surgery in people with Melanoma, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Paoli, Professor (0730404044, john.paoli@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate at 5 years. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06363591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.