Clinical Stage IA Cutaneous Melanoma AJCC v8NCT06673095
Narrow Excision Versus Wide Excision for the Treatment of Adults With Invasive Cutaneous Melanoma, ICEMAN Trial
A study testing Biospecimen Collection, Excision and Survey Administration in people with Clinical Stage IA Cutaneous Melanoma AJCC v8 and Clinical Stage IB Cutaneous Melanoma AJCC v8, run by OHSU Knight Cancer Institute at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Stage IA Cutaneous Melanoma AJCC v8, Clinical Stage IB Cutaneous Melanoma AJCC v8
- What is being tested?
- Biospecimen Collection, Excision and Survey Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 5 sitesUnited States
- Study dates
- 11 Dec 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Participants or legally authorized representatives (LAR) must provide written informed consent before any study-specific procedures or interventions are performed
- Age ≥ 18 years; all biological gender identities and racial/ethnic groups will be included
- Participants must have histologically confirmed primary cutaneous melanoma. Acral melanomas are eligible.
- Participants must have one of the following:
- American Joint Committee on Cancer (AJCC) 8th Ed clinical stage IA disease with Breslow thickness > 0.5 mm AND at least one high-risk feature (Mitotic rate ≥ 2/mm2, age ≤ 42, lymphovascular invasion, head/neck location)
- AJCC 8th Ed Clinical Stage IB melanoma
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- If a melanoma is widely transected and the true Breslow depth is uncertain, then to be eligible for this trial, the melanoma must be re-biopsied to ascertain an accurate Breslow depth.
- The index melanoma must be classified as low risk on the Merlin Assay (SkylineDx)
- Study intervention (surgery) must be completed within 120 days of the original diagnostic biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%)
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Participants with a history of HIV infection are eligible
- Participants can speak, read and write in English or Spanish
Who cannot join
- Uncertain diagnosis of melanoma (i.e. severely dysplastic nevi, melanocytic lesion of unknown malignant potential, atypical intraepidermal melanocytic proliferations)
- The patient has already undergone wide local excision at the site of the primary index lesion
- The patient has a pure desmoplastic melanoma. A pure desmoplastic melanoma is defined as being > 90% desmoplastic type. Melanomas with < 90% desmoplastic type may be included in this trial
- Mucosal and ocular melanomas are also excluded, as these are approached differently for surgical excision
- Physical, clinical, radiographic, or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma
- Participants with known or suspected cancer with regional or distant metastasis are excluded from this clinical trial because this trial is aimed at evaluating the control of localized disease
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- The patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, including a sentinel lymph node biopsy, of the index melanoma
- Planned adjuvant radiotherapy to the primary melanoma site after excision
- Participant is unwilling or unable to comply with study procedures
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan
Ann Arbor, Michigan, 48109
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
University of California, Davis
Davis, California, 95817
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To compare the 3-year local recurrence-free survival rates (RFS) in melanoma patients treated with narrow excision versus (vs) wide excision.
SECONDARY OBJECTIVES:
- 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.
- 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:
- 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.
- Conditions
- Clinical Stage IA Cutaneous Melanoma AJCC v8, Clinical Stage IB Cutaneous Melanoma AJCC v8
- Being tested
- Biospecimen Collection, Excision, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
ExcisionProcedure or surgery
Also called Abscission, Extirpation, Surgical Removal
Undergo narrow margin excision
ExcisionProcedure or surgery
Also called Abscission, Extirpation, Surgical Removal
Undergo wide margin excision
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (narrow margin excision) | Experimental | Patients undergo narrow margin excision on study. Patients may optionally undergo blood sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Procedure: Excision; Other: Survey Administration |
| Arm II (wide margin excision) | Active comparator | Patients undergo wide margin excision on study. Patients may optionally undergo blood sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Procedure: Excision; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence rate
Defined as average rate at which cancer returns to same location as the original tumor.
Measured: From randomization to end of year 3
Secondary outcomes (9)
Regional (nodal) disease-free survival
Average number of participants who are experiencing regional disease-free survival at 3 and 5 years.
Measured: From randomization to end of year 5
Local recurrence-free survival
The average length of time (in months) from the date of randomization to local recurrence.
Measured: From randomization to end of year 5
Melanoma-specific survival
The average length of time (in months) from date of randomization to death.
Measured: From randomization to end of year 5
Postoperative pain
Measured by numeric rating scale (0-10).
Measured: Up to 30 days after surgery
Quality of life
Quality of life score as measured by either the Facial Appearance, Quality of Life, and Experience Questionnaire (FACE-Q) score in patients with melanoma on the face or the Functional Assessment of Cancer Therapy - Melanoma (FACT-M) score for patients with melanoma elsewhere on the body. FACT-M is a tool for measuring health-related quality of life in patients with melanoma. It has 51 items, Scores range from 0 to 120 with higher score indicating better quality of life (QOL). FACE-Q includes 5 independently functioning scales and 2 checklists that measure outcomes important to patients from their perspective.
Measured: Up to postoperative day 90
Surgical complication rate
Defined as the proportion of patients experiencing a surgical complication.
Measured: Up to postoperative day 90
Frequency of complex reconstruction
Defined as the proportion of patients receiving any flap or graft reconstruction.
Measured: Immediately after surgery
Defect size
The size of the defect is measured as the greatest dimension of the final wound multiplied by the dimension perpendicular to the greatest dimension.
Measured: Immediately after surgery
Number of operative/procedure days
Will compare the number of operative/procedure days required to achieve negative margins. Will be reported and compared separately (Mohs surgery, narrow excision with permanent sections, wide excision with permanent sections, and slow Mohs).
Measured: Up to postoperative day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start11 Dec 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: Pending coordinating center transition
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 Clinical Stage IA Cutaneous Melanoma AJCC v8Studies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe 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
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Cynthia Morris, Ph.D., M.P.H., OHSU Knight Cancer Institute
- Investigators
- Cynthia Morris, Ph.D., M.P.H., Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673095
- Sponsor's protocol ID
- STUDY00027175
- Other IDs
- NCI-2024-08327, STUDY00027175
- Status last verified
- Sep 2026
- First submitted
- 22 Oct 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bichakjian CK, Swetter SM, Carroll BT, Vidal NY, Simons EA, Vetto JT, Yu WY. ICEMAN (Intelligent Choice of Excision Margin): A Randomized Controlled Trial of Adaptive Narrow Excision Versus Wide Excision for Adults with AJCC Stage I Cutaneous Melanoma. Ann Surg Oncol. 2025 Dec;32(13):9488-9490. doi: 10.1245/s10434-025-18282-w. Epub 2025 Sep 8.
PubMed 40921901
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06673095
- Acronym / sponsor ID
- STUDY00027175
- Conditions
- Clinical Stage IA Cutaneous Melanoma AJCC v8, Clinical Stage IB Cutaneous Melanoma AJCC v8
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Pending coordinating center transition
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Nov 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.
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:
- To compare the 3-year local recurrence-free survival rates (RFS) in melanoma patients treated with narrow excision versus (vs) wide excision.
SECONDARY OBJECTIVES:
- 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.
- 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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (narrow margin excision) | Experimental | Procedure: Biospecimen Collection, Procedure: Excision, Other: Survey AdministrationPatients undergo narrow margin excision on study. Patients may optionally undergo blood sample collection throughout the study. |
| Arm II (wide margin excision) | Active comparator | Procedure: Biospecimen Collection, Procedure: Excision, Other: Survey AdministrationPatients undergo wide margin excision on study. Patients may optionally undergo blood sample collection throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participants or legally authorized representatives (LAR) must provide written informed consent before any study-specific procedures or interventions are performed
- Age ≥ 18 years; all biological gender identities and racial/ethnic groups will be included
- Participants must have histologically confirmed primary cutaneous melanoma. Acral melanomas are eligible.
- Participants must have one of the following:
- The index melanoma must be classified as low risk on the Merlin Assay (SkylineDx)
Key exclusion criteria (9 listed)
- Uncertain diagnosis of melanoma (i.e. severely dysplastic nevi, melanocytic lesion of unknown malignant potential, atypical intraepidermal melanocytic proliferations)
- The patient has already undergone wide local excision at the site of the primary index lesion
- The patient has a pure desmoplastic melanoma. A pure desmoplastic melanoma is defined as being > 90% desmoplastic type. Melanomas with < 90% desmoplastic type may be included in this trial
- Mucosal and ocular melanomas are also excluded, as these are approached differently for surgical excision
- Physical, clinical, radiographic, or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Arm I (narrow margin excision), Arm II (wide margin excision) |
| ExcisionAlso: Abscission, Extirpation, Surgical RemovalUndergo narrow margin excision | Procedure or surgery | Arm I (narrow margin excision) |
| ExcisionAlso: Abscission, Extirpation, Surgical RemovalUndergo wide margin excision | Procedure or surgery | Arm II (wide margin excision) |
| Survey AdministrationAncillary studies | Other | Arm I (narrow margin excision), Arm II (wide margin excision) |
Primary outcome
Local recurrence rate
Time frame: From randomization to end of year 3
Defined as average rate at which cancer returns to same location as the original tumor.
9 secondary outcomes
Regional (nodal) disease-free survival
Time frame: From randomization to end of year 5
Local recurrence-free survival
Time frame: From randomization to end of year 5
Melanoma-specific survival
Time frame: From randomization to end of year 5
Postoperative pain
Time frame: Up to 30 days after surgery
Quality of life
Time frame: Up to postoperative day 90
Surgical complication rate
Time frame: Up to postoperative day 90
Frequency of complex reconstruction
Time frame: Immediately after surgery
Defect size
Time frame: Immediately after surgery
Number of operative/procedure days
Time frame: Up to postoperative day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Derived from this study: PubMed 40921901Bichakjian CK, Swetter SM, Carroll BT, Vidal NY, Simons EA, Vetto JT, Yu WY. ICEMAN (Intelligent Choice of Excision Margin): A Randomized Controlled Trial of Adaptive Narrow Excision Versus Wide Excision for Adults with AJCC Stage I Cutaneous Melanoma. Ann Surg Oncol. 2025 Dec;32(13):9488-9490. doi: 10.1245/s10434-025-18282-w. Epub 2025 Sep 8.
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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. This study is not recruiting at the moment.
Cynthia Morris, Ph.D., M.P.H. principal investigator
OHSU Knight Cancer Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Excision and Survey Administration in people with Clinical Stage IA Cutaneous Melanoma AJCC v8 and Clinical Stage IB Cutaneous Melanoma AJCC v8, run by OHSU Knight Cancer Institute at 5 sites in United States.
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 13 inclusion and 9 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: paused, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence rate (time frame: From randomization to end of year 3). 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 NCT06673095, 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 20 Oct 2026.