Natural History Study of Moles and Suspicious Melanoma (NCT00288938) | Clinical Trial Compass
CompletedNot Applicable
Natural History Study of Moles and Suspicious Melanoma
United States20 participantsStarted 2006-02-03
Plain-language summary
Background:
* Melanocytic nevi, or "moles," are non-cancerous growths of a type of skin cell called a melanocyte.
* Large congenital melanocytic nevi (LCMN) are a special type of mole that begins to grow before birth and is larger than moles that develop after birth.
* Determining how melanocytes in moles and LCMNs differ from normal melanocytes may increase the ability to predict whether a mole will give rise to a melanoma (a type of skin cancer)
Objectives:
* To understand how melanomas develop, by studying moles, LCMNs, and pigmented skin lesions that are suspicious for melanoma
* To develop better criteria for diagnosing melanoma, particularly by using a device called a digital dermatoscope (a special camera, connected to a computer, that takes pictures of moles when they are magnified and illuminated)
Eligibility:
* Children 5 years old or older with an LCMN
* Adults 18 years old or older with 100 or more moles larger than 2 mm in diameter and at least one 4 mm or more
* Adults 18 years old or older with a pigmented lesion suspicious for melanoma
Design:
* Patients' personal and family health history is obtained.
* Patients are examined by investigative team doctors, and several lesions are examined with a dermatoscope.
* Additional photographs of part or all of the skin surface may be taken.
* Some lesions may be biopsied.
* Additional tests or examinations may be recommended.
* Patients are followed periodically for skin or physical examinations, photography, laboratory and imaging evaluations, and possible skin biopsies.
* Children may undergo brain magnetic resonance imaging (MRI)
Who can participate
Age range
5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
Infants/Children
Must be less than or equal to 5 years.
Must have large congenital melanocytic nevus (LCMN, diagnosed clinically or by biopsy) that is greater than 20 cm in any one dimension or that is greater than 8 cm in any one dimension involving the scalp.
Must have outside referring physician.
OR
Adults
Must be greater than 18 years.
Must have greater than or equal to 100 melanocytic nevi greater than 2 mm in diameter.
Must have at least one melanocytic nevus greater than or equal to 4 mm in longest dimension.
Can have prior history of cutaneous or ocular malignant melanoma.
Must have outside primary physician.
OR
Adults
Must be greater than 18 years.
Must have a current pigmented lesion clinically suspicious for primary melanoma.
Must have outside primary physician.
AND
All patients, or in the case of infants and children their parents or legal guardians, must be able to understand and sign an informed consent.
EXCLUSION CRITERIA:
The patient does not meet the inclusion criteria.
Diagnosis of genetic syndrome associated with multiple lentigines or nevi (Peutz-Jeghers syndrome, Carney complex, turner syndrome, Noonan's syndrome).
Two or more first-degree relatives with history of cutaneous melanoma and familial atypical mole-melanoma syndrome phenotype.
Diagnosis of cancer-associated syndrome (xeroderma pigmentosum, type I neurofibromatosis, Li-Fraumeni syndrome).
Inability to tolerate surgical procedure due to bleeding diat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.