Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06228014 |
| Other study ID # |
PS2022074 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 7, 2022 |
| Est. completion date |
December 30, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
AI Labs Group S.L |
| Contact |
Alfonso Medela, MsC |
| Phone |
+34 638127476 |
| Email |
alfonso[@]legit.health |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The goal of this observational prospective and analytical study is to validate that the
device is a valid tool for improving the adequacy of referrals to dermatology. As a secondary
objectives the investigators set out to validate that the device reduces costs in secondary
care; to validate that the device reduces dermatology waiting lists and to validate that the
device optimizes clinical flow in Osakidetza.
The primary care physician will explain to the patient what his/her participation in the
study will consist of by means of the Patient Information Sheet. The patient, in turn, will
be able to ask all the questions he/she considers appropriate in order to clarify all his/her
doubts regarding the study. If the patient wishes to participate in the study, he/she will
sign the Informed Consent Form and will be assigned a study code. After signing the informed
consent, the data collection process begins. The Principal Investigator and/or collaborating
investigators assigned to this task will collect demographic data (age, sex) and data related
to the diagnosis, characteristics and treatment of the pathology.
Primary care physicians should take photographs showing the areas affected by the pathology.
These photographs will be taken with their own smartphone or using a mobile dermatoscope if
the use of a mobile dermatoscope is clinically relevant. The primary care physician, will
record the photographs periodically, uploading the images to a Google Drive folder that the
study sponsor will enable at the beginning of the study. The photographs are named using a
code that includes the patient ID (NNN) and photograph number (nn).
Primary care physicians will assess the patient's pathology as they would in a routine
consultation and record their diagnosis and referral criteria, and associate them with the
patient's photographs and demographic data to be collected by the research team
telematically at the end of the study duration.
These information transfers and the storage of the photographs will be in line with the
European Regulation 2016/679 of 27 April on the protection of natural persons with regard to
the processing of personal data and the free movement of such data and the Organic Law 3/2018
of 5 December on the Protection of Personal Data and guarantee of digital rights.
The specialist physicians will have a period of one month after the end of the recruitment
period to evaluate and label the photographs taken. In this labeling process they will record
their diagnosis, and whether they consider that the referral has been appropriate or not.
This information will be collected by the research team telematically at the end of the study
duration.
This transfer of information and storage of the photographs will comply with European
Regulation 2016/679, of 27 April, on the protection of natural persons with regard to the
processing of personal data and the free movement of such data and with Organic Law 3/2018,
of 5 December, on the Protection of Personal Data and guarantee of digital rights.
Description:
Skin-related diseases are a frequent reason for consultation in primary care; some studies
quantify it at approximately 5% of all consultations made, mainly by the working population.
This represents a considerable consumption of resources and makes an efficient approach to
these conditions a key step in optimizing the performance of primary care.
Many studies show discrepancies in opinion between the opinions of primary care physicians
and dermatologists, with percentages of agreement in their diagnoses ranging from 57% to
65.52% depending on the study. In general, primary care physicians do not demonstrate
adequate knowledge of skin diseases, their diagnosis and treatments.
This human limitation when evaluating skin diseases is also reflected in the effort and time
required to estimate the degree of involvement of a patient or the stage of the pathology. So
much so, that it ends up being a very unrewarding task and can lead to poor adherence to the
protocol and inadequate referrals.
Time consumption is of particular concern given that the number of medical professionals,
especially in dermatology, is not sufficient in relation to the demand that exists. Access of
the general population to a dermatology specialist is complicated, due to the low number (3
dermatologists per 100,000 inhabitants), making it even more difficult in small population
centers. Because of this, screening for dermatologic lesions should be performed by the
primary care physician, whose diagnostic capacity is even lower and can increase the risk of
misdiagnosis.
In this regard, the literature shows a discordance of 55% to 65% between the primary care
physician and the specialist6 and studies confirm a number of expected features: common
dermatological diseases are often unrecognized or misdiagnosed by non-dermatologists, due to
the particular profiles of common diagnoses in this activity (drug-induced rash, fungal
infections).
And in addition to these inherent limitations, in cases where the preliminary examination is
performed by the patient, the possibility of bias is added. This is especially true in cases
where the patient knows that the treatment he or she receives will be determined by the
information he or she provides. In addition, the medical team lacks the means to ensure that
the values reported by the patient are true, which precludes external verification.
Fortunately, in recent years there has been an increasing demand to develop Computer Aided
Diagnosis (CAD) systems and other systems that facilitate the detection of different
pathologies through algorithms. CAD systems are an interdisciplinary technology that combines
artificial intelligence and digital image processing. Image processing based on complex
pattern recognition systems makes it possible for the physician to interpret the information
contained in the medical image with much less difficulty. Advances in image recognition and
artificial intelligence have led to innovations in the diagnosis of all types of pathologies.
It has been demonstrated that through artificial intelligence (AI) algorithms it is possible
to classify photographs of lesions with a level of competence comparable to that of a medical
expert.
Therefore, the use of artificial vision applications when gathering information about the
patient's condition presents a huge advance that not only brings reliability to the
documentation process, but also allows greater precision when measuring visual signs of the
pathology, and consequently, informs the criteria for referral to the specialist.
Consequently, this study aims to clinically validate a novel artificial intelligence tool for
activity grading in affected patients.
This innovation has the potential to facilitate medical practice in the diagnosis of skin
cancer and improve the quality of life of patients affected by this pathology. In addition,
this technology provides a new measurement tool that opens the door to a new field of
research into the efficacy of treatments or the analysis of the pathology itself and its
subtypes.
The hypothesis guiding this study is that artificial intelligence algorithms developed by AI
LABS GROUP SL significantly optimize the appropriateness of dermatology referrals.
The main objective of this study is to validate that the artificial intelligence algorithms
developed by AI LABS GROUP SL optimize the appropriateness of referrals to dermatology. That
is, to reduce the number of mild or benign cases that are referred to the dermatologist,
since they can be managed from primary care.
This is an analytical prospective observational study of a series of clinical cases. It is a
longitudinal study.
This study estimates a recruitment period of 2 months. The specialist physicians will have 1
month to label the photographs. The investigators will have 1 month to close and edit the
database, analyze the data, and prepare the final report of the study.
The total duration of the study is estimated at 4 months.
"proof-of-concept" pilot study in which the sample size has been estimated based on
the number of patients with a diagnosis of skin diseases that can be seen in four primary
care services of Hospital Universitario de Cruces. During the recruitment period of the
study, all patients with a diagnosis of skin diseases who meet the selection criteria will be
included. The data collected from these patients during the study period will be analyzed,
and depending on the results obtained, it will be assessed whether it is necessary to expand
the sample size to include more patients.
The main variable aims to determine the efficiency of the algorithm in optimizing the
appropriateness of dermatology referrals.
To this end, the researchers will identify inappropriate referrals. The investigators define
an inappropriate referral as one that, according to the criteria of the specialists consulted
in the study, does not require the attention of a dermatologist in order to be treated, as
may be the case of seborrheic keratosis. For this purpose, a photograph will be taken and the
date of the patient's visit to the clinic and the criteria for moving to the next stage
of the care process will be recorded. That is to say: the date of the visit attended by the
primary care physician and whether or not it resulted in a referral to a dermatologist, as
well as the referral criterion used, will be recorded. In addition, a photograph of the area
affected by the pathology will be taken at this step. Later, the Principal Investigators will
evaluate the photos and determine whether the referral was appropriate or not.
