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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02511119
Other study ID # JRR-MEL-2015
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 28, 2015
Last updated July 29, 2015
Start date July 2015

Study information

Verified date July 2015
Source Maimónides Biomedical Research Institute of Córdoba
Contact Blanca Quijano-Ruiz, Pharmacist
Phone (+34) 677 906 567
Email blanca.quijano@imibic.org
Is FDA regulated No
Health authority Comité Ético de Investigación Clínica Spain:
Study type Observational

Clinical Trial Summary

The aim of this study is to develop a predictive model of risk of developing melanoma. The investigators will used artificial intelligence techniques to analysed images patterns obtained by clinical and dermoscopic pictures. The investigators want to defined a new predictive risk model obtained from genetic information and image analysis of pigmented lesions. This model could help to discriminate more accurately those patients who are most likely to develop melanoma in a high-risk population.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- =18 years of age;

- Followed up patients in the Pigmented Lesions Unit at Reina Sofia University Hospital with high risk of developing melanoma (First-degree family/personal history of familiar melanoma and/or melanocyticnevi above 50 and/or dysplastic or atypical nevi);

- All nevi for which there is at least one dermatoscopy registry will be included.

Exclusion Criteria:

- not enough data in the patient clinical history;

- located lesions on the face, scalp, mucous membrane or on acral área;

- nodular or metastatic melanoma diagnosis

- type V or VI of Fitzpatrick phototyping scale

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Maimónides Biomedical Research Institute of Córdoba Mount Sinai Hospital, New York

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with Melanoma Three years No
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