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Compares treatment options for Clinical Stage IA Cutaneous Melanoma AJCC v8
Official title Narrow Excision Versus Wide Excision for the Treatment of Adults With Invasive Cutaneous Melanoma, ICEMAN Trial
ClinicalTrials.gov ID: NCT06673095
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants or legally authorized representatives (LAR) must provide written informed consent before any study-specific procedures or interventions...
- 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...
You likely can't join if
- Uncertain diagnosis of melanoma (i.e. severely dysplastic nevi, melanocytic lesion of unknown malignant potential, atypical intraepidermal...
- 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%...
- 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...
See the full eligibility criteria
- 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
- 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 how well it works assessment of the investigational regimen are eligible for...
- Participants with a history of HIV infection are eligible
- Participants can speak, read and write in English or Spanish
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Davis, California, United States
- Lexington, Kentucky, United States
- Ann Arbor, Michigan, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Davis, California, United States; Lexington, Kentucky, United States; Ann Arbor, Michigan, United States; Cleveland, Ohio, United States; Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.