Melanoma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with Stage II invasive skin melanoma of a specific thickness and ulceration status, confirmed by biopsy and laboratory analysis.
• People whose melanoma is on the skin (including the head, neck, trunk, arms, legs, scalp, palms, or soles of the feet).
• People where a 2cm clear border around the biopsy scar or melanoma site is physically possible to achieve with surgery.
• People who are able to have the required surgery (sentinel lymph node biopsy and wide local excision on the same day) within 120 days of their original diagnosis, and within 28 days of being enrolled in the trial.
• People aged 18 or older at the time of giving consent.
• People who are able to give informed consent and follow the treatment and follow-up plan required by the trial.
• People whose general health, aside from the melanoma, is expected to support a life expectancy of at least 5 years, as assessed by the treating doctor.
• People who have a good level of physical functioning, as measured by a standard medical score (ECOG score of 0 or 1) at the screening stage.
• People with a history of a previous cancer may be considered if: all prior cancers were treated with the intent to cure; there has been no sign of those cancers returning for at least five years (with some exceptions for certain skin or uterine/cervical cancers); and the treating doctor considers the risk of those cancers returning to be low.

Who may not be able to join:

• People where the diagnosis of melanoma is uncertain or unclear.
• People who have already had a wide local excision surgery at the melanoma site.
• People who are not able to have a sentinel lymph node biopsy for their melanoma.
• People whose melanoma involves nerve invasion (called perineural invasion or neurotropism).
• People whose melanoma is confirmed as "pure desmoplastic melanoma" (more than 90% desmoplasia as defined by the WHO); mixed or less than 90% desmoplastic types may still be considered unless nerve invasion is present (confirm with trial site).
• People whose pathology report shows microsatellitosis (small clusters of tumour cells found separate from the main melanoma, as defined by AJCC 8th edition guidelines).
• People whose melanoma is located under a fingernail or toenail (subungual melanoma).
• People who have already had a local flap reconstruction surgery at the melanoma site, making it impossible to accurately measure the excision margin.
• People with a history of a previous or second simultaneous invasive melanoma.
• People whose melanoma is located past the knuckles of the hand, on the tip of the nose, on the eyelids, on the ear, on the genitals, around the anus or perineum, or on mucous membranes or internal organs.
• People who have any signs — physical, imaging-based, or from pathology — that the melanoma has spread to nearby or distant areas of the body.
• People who have already had lymph node surgery (including a sentinel lymph node biopsy) related to the same melanoma on a separate occasion.
• People who have had another solid or blood cancer diagnosed in the past 5 years (with the exception of certain low-risk skin cancers or uterine/cervical cancer).
• People who have had melanoma-related procedures that do not match what is allowed under the trial protocol (confirm with trial site).
• People for whom additional radiation therapy to the melanoma site after surgery is planned, as this is not permitted in the trial.
• People who have a history of organ transplantation.
• People who have been taking oral or injectable immunosuppressive medications (not including topical creams or inhaled steroids) at the time of enrolment or within the 6 months before enrolment.
• People who are pregnant may face difficulty meeting the surgery timing requirement, which could affect eligibility; the trial site advises careful discussion with the treating team before enrolment is considered (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.