MelaFind Evaluations for Patients With Multiple Nevi
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveCohorte
Suivi d'un groupe de personnes dans le temps pour mieux comprendre les causes et l'évolution d'une maladie.Résumé
Date de début de l'étude : 1 novembre 2012
Date à laquelle le premier participant a commencé l'étude.We have added objectives 4-6 to our updated study: Study Objective 1: To determine whether the distribution of MelaFind scores is different for different patients with multiple nevi, and whether such distributions can be utilized to identify "signature" lesions for a given patient. Study Objective 2: To investigate whether distributions of quantitative ABCD parameters differ among patients and whether these qABCD parameters identify "signature" lesions. Study Objective 3: To determine the feasibility of defining and using relative thresholds to improve the specificity of MelaFind without sacrificing its high sensitivity. Study Objective 4: To determine the repeatability of MelaFind scores for a given lesion for different patient and lesion characteristics. Study Objective 5: To identify patient and lesion characteristics that result in the highest variability of MelaFind scores for a given lesion. Study Objective 6: To use standard errors of MelaFind scores to propose a robust individual threshold for lesions to be considered for biopsy to rule out melanoma on patients with multiple nevi.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.19 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cohorte
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Critères
Cutaneous lesions examined with MelaFind must satisfy all of the following inclusion criteria: Inclusion Criteria: The lesion is pigmented (i.e., melanin, keratin, blood) The diameter of the pigmented area is not < 2 mm, and not > 22 mm The lesion is accessible to the MelaFind The patient, or a legally authorized representative, has consented to participate in the study and has signed the Informed Consent Form; Cutaneous lesions that meet any of the following exclusion criteria will not be accepted: Exclusion Criteria: The patient has a known allergy to isopropyl alcohol The lesion has been previously biopsied, excised, or traumatized The skin is not intact (e.g., open sores, ulcers, bleeding) The lesion is within 1 cm of the eye The lesion is on mucosal surfaces (e.g., lips, genitals) The lesion is on palmar hands The lesion is on plantar feet The lesion is on or under nails The lesion is located on or in an area of visible scarring The lesion contains foreign matter (e.g., tattoo, splinter, marker)
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux