Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
NCT ID:
NCT06673095
Brief Summary:
This clinical trial compares the effect of a narrow surgical excision (removal) to a wide excision for the treatment of adults with invasive cutaneous melanoma. Currently the standard of care is to take wide margins (boarder of healthy tissue surrounding the melanoma) when removing melanoma. Narrow margin excision removes a smaller amount of healthy tissue when surgically removing the melanoma. Narrow margin excision may be effective in removing the melanoma while also reducing surgical complications and improving quality of life for adults with invasive cutaneous melanoma.
Detailed Description:
PRIMARY OBJECTIVE:
I. To compare the 3-year local recurrence-free survival rates (RFS) in melanoma patients treated with narrow excision versus (vs) wide excision.
SECONDARY OBJECTIVES:
I. To measure the 3-, 5-year Regional (nodal) disease-free survival (DFS) in melanoma patients treated with active nodal surveillance.
II. To compare 5-year local recurrence-free survival in patients treated with narrow vs wide excision.
III. To compare 5-year Melanoma Specific Survival (MSS) in patients treated with narrow vs wide excision.
IV. To compare the quality of life in patients treated with narrow vs wide excision.
V. To compare surgical complication rates in patients treated with narrow vs wide excision.
VI. To compare the frequency of complex reconstruction in patients treated with narrow vs wide excision.
VII. To compare the final defect size in patients treated with narrow vs wide excision.
VIII. To compare the number of operative/procedure days required to achieve negative margins.
EXPLORATORY OBJECTIVE:
I. To measure the T- and B-cell repertoires in patients with melanoma over time.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo narrow margin excision on study. Patients may optionally undergo blood sample collection throughout the study.
ARM II: Patients undergo wide margin excision on study. Patients may optionally undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 1 week, 3, 6, 12, 36, 48, and 60 months.
Study:
NCT06673095
Study Brief:
Protocol Section:
NCT06673095