Atypical MOLes and Melanoma Early Detection Study (MoleMed) (NCT04353050) | Clinical Trial Compass
UnknownNot Applicable
Atypical MOLes and Melanoma Early Detection Study (MoleMed)
Russia350 participantsStarted 2020-04-01
Plain-language summary
This is a multicenter, ambispective, low-interventional clinical study evaluating molecular genetic markers for non-invasive differential diagnosis of benign and malignant pigmented skin and mucosal neoplasms. In retrospective cohorts genetics markers will be identified. In prospective cohort non-invasive adhesive system will be tested to identify malignant or benign lesions with prespecified sensitivity and specificity compared to other non-invasive techniques (i.e. dermoscopy) and using histopathological examination as a "golden standard".
Who can participate
Age range
18 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:
Cohort 1 (retrospective):
* Histologically confirmed diagnosis of melanocytic neoplasm of the skin or mucous membranes (benign, malignant or with unclear potential);
* The presence of a paraffin block with a tumor suitable for molecular genetic analysis;
* Signed informed consent form for living patients (for deceased, signing of a consent form with legal representatives is not required);
* Patient's age is over 18 years for the period of inclusion in the study (at the time of signing the consent form for living patients or for the excision biopsy period for deceased patients);
* Known clinical data of the patient (gender, age, skin phototype), hereditary history, medical history and follow-up of treatment outcomes for at least 5 years
2\. Cohort 2 (retrospective):
* Histologically confirmed diagnosis of melanocytic neoplasm of the skin or mucous membranes (benign, malignant or with unclear potential);
* The presence of a paraffin block with a tumor suitable for molecular genetic analysis
* The presence of cytological preparations (at least 2 glasses) of the primary tumor with tumor material
* Signed informed consent form for living patients (for deceased, signing of a consent form with legal representatives is not required);
* Patient's age is over 18 years for the period of inclusion in the study (at the time of signing the consent form for living patients or for the excision biopsy period for deceased patients);
* A known medical history and follow…
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.
What they're measuring
1
Sensitivity and specificity on the investigated non-invasive genetic method for diffrential diagnosis of benign and malignant melanocytic lesions compared to histopathological examination