Basal Cell CarcinomaBCC-AINCT07677124
AI-Based Risk Classification and Histopathological Subtype Prediction of Basal Cell Carcinoma Using Dermoscopic Images
An observational study of Basal Cell Carcinoma, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This retrospective observational study aims to develop and evaluate a convolutional neural network (CNN)-based artificial intelligence model for risk classification and histopathological subtype prediction of basal cell carcinoma (BCC) using clinical and dermoscopic images. Read more about this study
- Who is it for?
- Ages 0 to 100 years
- Conditions the study is for
- Basal Cell Carcinoma
- How many people
- 2,500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 May 2026to 22 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of patients with histopathologically confirmed basal cell carcinoma who have dermoscopic images of sufficient quality for artificial intelligence analysis and documented histopathological subtype information. Archived clinical and dermoscopic images collected at Istanbul Training and Research Hospital will be retrospectively analyzed.
Who may be able to join
- Patients with histopathologically confirmed basal cell carcinoma.
- Cases with a specified histopathological subtype.
- Availability of dermoscopic images with sufficient image quality and resolution for artificial intelligence analysis.
Who cannot join
- Cases without histopathological confirmation of basal cell carcinoma.
- Cases with unspecified histopathological subtype.
- Images with insufficient quality or resolution for artificial intelligence analysis.
- Cases without available dermoscopic images.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Training and Research Hospital
Istanbul, Istanbul, 34000
Ayse Esra Koku Aksu, MD, +905059126069, esraaksu@gmail.com
tugce nur izbudak kara, MD, +905395976598, eizbudak@icloud.com
About this study
Official title: Risk Classification and Prediction of Histopathological Subtypes in Basal Cell Carcinoma Using a CNN-Based Artificial Intelligence Model on Dermoscopic Images
This retrospective observational study aims to develop and evaluate a convolutional neural network (CNN)-based artificial intelligence model for risk classification and histopathological subtype prediction of basal cell carcinoma (BCC) using clinical and dermoscopic images. Histopathologically confirmed BCC cases from a dermatology archive will be included. The primary objective is to assess the diagnostic performance of the CNN model in classifying BCC as low-risk or high-risk. Secondary objectives include predicting histopathological subtypes and comparing the model's performance with that of dermatology physicians. Histopathological diagnosis will serve as the reference standard. All archived data will be anonymized before analysis.
Read the detailed description
Basal cell carcinoma (BCC) is the most common skin malignancy and comprises histopathological subtypes with different biological behaviors, recurrence risks, and treatment implications. Accurate identification of high-risk and low-risk subtypes is important for clinical decision-making. Dermoscopy improves diagnostic accuracy in BCC; however, prediction of histopathological risk categories based solely on dermoscopic findings remains challenging.
This retrospective observational study will use archived clinical and dermoscopic images, histopathology reports, and clinical records of patients with histopathologically confirmed BCC. All data will be anonymized before analysis. Images containing identifiable patient information will be excluded.
A convolutional neural network (CNN)-based artificial intelligence model will be developed using clinical and dermoscopic images. Images will undergo preprocessing, including standardization of image size, normalization procedures, and removal of potentially identifiable information. The dataset will be divided into training, validation, and test sets while maintaining separation at the patient level to avoid data leakage.
The primary outcome is the diagnostic performance of the CNN model for classification of BCC into low-risk and high-risk histopathological groups. Secondary outcomes include prediction of histopathological subtypes and comparison of model performance with dermatologist assessments. Histopathological diagnosis will serve as the reference standard.
Model performance will be evaluated using accuracy, sensitivity, specificity, precision, recall, F1 score, and area under the receiver operating characteristic curve (ROC-AUC). Comparisons between the artificial intelligence model and physician assessments will be performed using appropriate statistical methods. Interobserver agreement may also be assessed when applicable.
- Conditions
- Basal Cell Carcinoma
- Keywords
- Basal Cell Carcinoma, Artificial Intelligence, Convolutional Neural Network, Dermoscopy, Skin Cancer, Histopathological Subtypes, Risk Classification
- Medical subject headings
- Carcinoma, Basal Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low-Risk Basal Cell Carcinoma | Patients with histopathologically confirmed low-risk basal cell carcinoma, including nodular, superficial, pigmented, adenoid, solid, and nodulocystic subtypes. Clinical and dermoscopic images will be used for artificial intelligence-based risk classification and subtype prediction. | |
| High-Risk Basal Cell Carcinoma | Patients with histopathologically confirmed high-risk basal cell carcinoma, including infiltrative, micronodular, morpheaform, and basosquamous subtypes. Clinical and dermoscopic images will be used for artificial intelligence-based risk classification and histopathological subtype prediction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of artificial intelligence-based classification of basal cell carcinoma risk groups
Diagnostic accuracy of the convolutional neural network model in distinguishing low-risk and high-risk basal cell carcinoma using dermoscopic images, compared with histopathological diagnosis as the reference standard.
Measured: Baseline
Secondary outcomes (2)
Diagnostic accuracy (accuracy, sensitivity, specificity, F1-score and ROC-AUC) of convolutional neural network for histopathological subtype prediction of basal cell carcinoma using dermoscopic images
Diagnostic performance of the convolutional neural network in predicting histopathological subtypes of basal cell carcinoma from dermoscopic images compared with histopathological diagnosis (reference standard). Diagnostic accuracy will be assessed using accuracy, sensitivity, specificity, precision, F1-score and ROC-AUC.
Measured: baseline
Diagnostic accuracy (accuracy, sensitivity, specificity, F1-score and ROC-AUC) of artificial intelligence compared with dermatologists for basal cell carcinoma risk classification
Comparison of diagnostic performance between the artificial intelligence model and dermatologists in risk classification of basal cell carcinoma. Performance will be assessed using accuracy, sensitivity, specificity, precision, F1-score and ROC-AUC.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start22 May 2026
- Primary completion22 May 2027 (estimated)
- Study completion22 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tugce Nur Izbudak Kara, Istanbul Training and Research Hospital
- Investigators
- Ayse Esra Koku Aksu, MD, Principal investigator, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677124
- Sponsor's protocol ID
- SBU-IEAH-DERM-BCCAI-163
- Other IDs
- IEAH-EC-163
- Acronym
- BCC-AI
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Classification and Prediction of Histopathological Subtypes in Basal Cell Carcinoma Using a CNN-Based Artificial Intelligence Model on Dermoscopic Images
- ClinicalTrials.gov ID
- NCT07677124
- Acronym / sponsor ID
- BCC-AI / SBU-IEAH-DERM-BCCAI-163
- Conditions
- Basal Cell Carcinoma
- Keywords
- Basal Cell Carcinoma, Artificial Intelligence, Convolutional Neural Network, Dermoscopy, Skin Cancer, Histopathological Subtypes, Risk Classification
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 22 May 2026 (actual)
- Primary completion
- 22 May 2027 (estimated)
- Study completion
- 22 May 2027 (estimated)
- First posted
- 30 Jun 2026 (actual)
- 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.
This retrospective observational study aims to develop and evaluate a convolutional neural network (CNN)-based artificial intelligence model for risk classification and histopathological subtype prediction of basal cell carcinoma (BCC) using clinical and dermoscopic images. Histopathologically confirmed BCC cases from a dermatology archive will be included. The primary objective is to assess the diagnostic performance of the CNN model in classifying BCC as low-risk or high-risk. Secondary objectives include predicting histopathological subtypes and comparing the model's performance with that of dermatology physicians. Histopathological diagnosis will serve as the reference standard. All archived data will be anonymized before analysis.
Detailed description
Basal cell carcinoma (BCC) is the most common skin malignancy and comprises histopathological subtypes with different biological behaviors, recurrence risks, and treatment implications. Accurate identification of high-risk and low-risk subtypes is important for clinical decision-making. Dermoscopy improves diagnostic accuracy in BCC; however, prediction of histopathological risk categories based solely on dermoscopic findings remains challenging.
This retrospective observational study will use archived clinical and dermoscopic images, histopathology reports, and clinical records of patients with histopathologically confirmed BCC. All data will be anonymized before analysis. Images containing identifiable patient information will be excluded.
A convolutional neural network (CNN)-based artificial intelligence model will be developed using clinical and dermoscopic images. Images will undergo preprocessing, including standardization of image size, normalization procedures, and removal of potentially identifiable information. The dataset will be divided into training, validation, and test sets while maintaining separation at the patient level to avoid data leakage.
The primary outcome is the diagnostic performance of the CNN model for classification of BCC into low-risk and high-risk histopathological groups. Secondary outcomes include prediction of histopathological subtypes and comparison of model performance with dermatologist assessments. Histopathological diagnosis will serve as the reference standard.
Model performance will be evaluated using accuracy, sensitivity, specificity, precision, recall, F1 score, and area under the receiver operating characteristic curve (ROC-AUC). Comparisons between the artificial intelligence model and physician assessments will be performed using appropriate statistical methods. Interobserver agreement may also be assessed when applicable.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Risk Basal Cell Carcinoma | – | –Patients with histopathologically confirmed low-risk basal cell carcinoma, including nodular, superficial, pigmented, adenoid, solid, and nodulocystic subtypes. Clinical and dermoscopic images will be used for artificial intelligence-based risk classification and subtype prediction. |
| High-Risk Basal Cell Carcinoma | – | –Patients with histopathologically confirmed high-risk basal cell carcinoma, including infiltrative, micronodular, morpheaform, and basosquamous subtypes. Clinical and dermoscopic images will be used for artificial intelligence-based risk classification and histopathological subtype prediction. |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of patients with histopathologically confirmed basal cell carcinoma who have dermoscopic images of sufficient quality for artificial intelligence analysis and documented histopathological subtype information. Archived clinical and dermoscopic images collected at Istanbul Training and Research Hospital will be retrospectively analyzed.
Key inclusion criteria (3 listed)
- Patients with histopathologically confirmed basal cell carcinoma.
- Cases with a specified histopathological subtype.
- Availability of dermoscopic images with sufficient image quality and resolution for artificial intelligence analysis.
Key exclusion criteria (4 listed)
- Cases without histopathological confirmation of basal cell carcinoma.
- Cases with unspecified histopathological subtype.
- Images with insufficient quality or resolution for artificial intelligence analysis.
- Cases without available dermoscopic images.
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
Accuracy of artificial intelligence-based classification of basal cell carcinoma risk groups
Time frame: Baseline
Diagnostic accuracy of the convolutional neural network model in distinguishing low-risk and high-risk basal cell carcinoma using dermoscopic images, compared with histopathological diagnosis as the reference standard.
2 secondary outcomes
Diagnostic accuracy (accuracy, sensitivity, specificity, F1-score and ROC-AUC) of convolutional neural network for histopathological subtype prediction of basal cell carcinoma using dermoscopic images
Time frame: baseline
Diagnostic accuracy (accuracy, sensitivity, specificity, F1-score and ROC-AUC) of artificial intelligence compared with dermatologists for basal cell carcinoma risk classification
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Yes
Related trials for Basal Cell Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients
Basal Cell Carcinoma (BCC), First Line Treatment
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
A Study Comparing Cemiplimab-based Treatments for Adult Participants With Locally Advanced Basal Cell Skin Cancer (laBCC)
Locally Advanced Basal Cell Carcinoma
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.
Ayse Esra Koku Aksu, MD principal investigator
Istanbul Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Cell Carcinoma, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
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: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tugce Nur Izbudak Kara, MD (+905395976598, eizbudak@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of artificial intelligence-based classification of basal cell carcinoma risk groups (time frame: Baseline). 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 Jun 2026.