MelanomaNCT02511119
Application of Genomic Techniques and Image Processing Using Artificial Intelligence to Obtain a Predictor Model Risk of Melanoma
An observational study of Melanoma, run by Maimónides Biomedical Research Institute of Córdoba.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients were followed up in the Pigmented Lesions Unit at Reina Sofia University Hospital. In a subgroup of 200 patients, the investigators will analyze the dermoscopic imagines of melanocytic nevus, atypical nevus and melanomas to seek common patterns using artificial intelligence methods. With the patterns obtained, the investigators will build a robust model to classify population with the risk of developing melanoma. In this model the sociodemographic, clinical and genetic data will be used to increase the accuracy of the obtained model. In a second phase, in a subgroup of 100 different patients, the degree of accuracy of the predictive model will be evaluated.
Who may be able to join
- ≥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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Melanoma
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Melanoma
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Sinai Hospital, New York
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511119
- Sponsor's protocol ID
- JRR-MEL-2015
- Status last verified
- Jul 2015
- First submitted
- 28 Jul 2015
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Genomic Techniques and Image Processing Using Artificial Intelligence to Obtain a Predictor Model Risk of Melanoma
- ClinicalTrials.gov ID
- NCT02511119
- Acronym / sponsor ID
- JRR-MEL-2015
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Collaborators
- Mount Sinai Hospital, New York
- Study start
- Jul 2015
- Primary completion
- Jul 2018 (estimated)
- First posted
- 29 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients were followed up in the Pigmented Lesions Unit at Reina Sofia University Hospital. In a subgroup of 200 patients, the investigators will analyze the dermoscopic imagines of melanocytic nevus, atypical nevus and melanomas to seek common patterns using artificial intelligence methods. With the patterns obtained, the investigators will build a robust model to classify population with the risk of developing melanoma. In this model the sociodemographic, clinical and genetic data will be used to increase the accuracy of the obtained model. In a second phase, in a subgroup of 100 different patients, the degree of accuracy of the predictive model will be evaluated.
Key inclusion criteria (3 listed)
- ≥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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with Melanoma
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Maimónides Biomedical Research Institute of Córdoba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Blanca Quijano-Ruiz, Pharmacist ((+34) 677 906 567, blanca.quijano@imibic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Melanoma (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.