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 aged 18 or older at the time of enrolment.
• People who are willing and able to follow all study procedures for the full duration of the trial, and who have signed and dated a consent form.
• People whose overall health and ability to carry out daily activities falls within a certain range, based on a standard medical scoring scale called ECOG, with scores of 0 (fully active), 1 (restricted in strenuous activity but able to do light work), or 2 (up and about more than half of waking hours) (confirm with trial site).
• People who have been confirmed by biopsy to have melanoma that has spread to exactly one lymph node in the armpit, groin, or pelvic area, where that lymph node was detectable either by physical examination or by specific scan or size measurements — including cases where that node has already been surgically removed within the 8 weeks before enrolment, provided it met the required detection criteria before removal.
• People who are medically able to undergo a single lymph node removal procedure (called LNEx), and who are not enrolled in another clinical trial that requires full lymph node dissection.
• People who previously had melanoma spread to a sentinel lymph node in the same area, provided a full lymph node dissection was not performed at that time, and at least one year has passed since that earlier positive sentinel node biopsy.
• People who have had the required scans — a PET-CT scan and either a head CT scan or an MRI — showing no signs of melanoma spread elsewhere in the body. These scans may have been done before primary melanoma removal or sentinel node biopsy, if they showed no other spread.

Who may not be able to join:

• People who have previously had a full lymph node dissection, or radiation therapy, to the lymph node area now affected.
• People who have had, or currently have, melanoma that has spread through the skin (called in-transit or satellite metastases) from the same melanoma that spread to the lymph node being studied — with a limited exception for people whose skin spread occurred more than one year before enrolment and has not come back since (confirm with trial site).
• People who have had, or currently have, melanoma that has spread to parts of the body beyond the main nearby lymph node area — though people with very small, unclear findings on scans that doctors would normally monitor rather than treat may still be considered eligible (confirm with trial site).
• People who already have swelling in the limbs (lymphedema) in a way that would make it impossible to measure any changes in swelling after surgery — though people with mild and stable swelling may still be considered in some cases (confirm with trial site).
• People whose treating doctors plan to give radiation therapy to the affected lymph node area after surgery, as this would interfere with the study's measurements.
• People for whom the treating investigator considers there to be a medical reason they cannot safely or reliably follow the study's requirements.
• People who are currently receiving, or have received within the past 3 months, systemic or local treatment directed at this melanoma — with a limited exception for people receiving pre-surgery (neoadjuvant) therapy at a participating centre who otherwise meet all other criteria (confirm with trial site).
• People with another current or past cancer may not be eligible if that cancer or its treatment could interfere with the safety or results of this study (confirm with trial site).

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