Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-01 @ 10:31 AM
Study NCT ID:
NCT06673095
Status:
RECRUITING
Last Update Posted:
2025-05-23
First Post:
2024-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Narrow Excision Versus Wide Excision for the Treatment of Adults With Invasive Cutaneous Melanoma, ICEMAN Trial
Sponsor:
OHSU Knight Cancer Institute
Organization:
Study Overview
Official Title:
ICEMAN (Intelligent Choice of Excision Margin): A Randomized Controlled Trial of Narrow Excision Versus Wide Excision for Adults With Primary Invasive Cutaneous Melanomas
Status:
RECRUITING
Status Verified Date:
2025-05
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:
None
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.
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 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?: