Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363591
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-03-28
Brief Title:
Single- vs Two-staged Excisions of Thin Melanoma
Sponsor:
Vastra Gotaland Region
Organization:
Vastra Gotaland Region
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WvW
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
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 10 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 15 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 andor death for patients with thin melanomas 1mm Breslow thickness treated with only one excision compared to the current standard of two excisions
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 10 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 15 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 andor death for patients with thin melanomas 1mm Breslow thickness treated with only one excision compared to the current standard of two excisions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None