LymphedemaCDTLNCT07485465
Lymphoedema Diagnosis and Treatment
An observational study of Lymphedema and Artificial Intelligence (AI), run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
A domain-specific, custom-trained large language model for the differential diagnosis and treatment planning of lymphedema, lipedema, and venous insufficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema, Artificial Intelligence (AI)
- What is being tested?
- a domain-specific, custom-trained large language model for the differential diagnosis and treatment planning of lymphedema, lipedema, and venous insufficiency
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2026to 1 Apr 2026
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: secondary lymphedema cases (post-pelvic surgery, post-breast cancer), primary lymphedema cases, lipedema cases (different types and stages), chronic venous insufficiency cases, mixed edema cases, and atypical presentations with diagnostic difficulties
Who may be able to join
- Patients over the age of 18
- Clinical diagnosis of lymphoedema
- Clinical diagnosis of lipoedema
- Clinical diagnosis of venous insufficiency
Who cannot join
- Lack of medical history
- Lack of demographic data
- Lack of clinical data and
- Lack of imaging methods
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
Istanbul Fatih Sultan Mehmet Training and Research Hospital
Istanbul, Istanbul, 34704
İlknur Aktaş, MD, Prof., +90 533 714 63 52, iaktas@hotmail.com
About this study
Official title: The Role of Chat GPT in the Diagnosis and Treatment of Lymphedema
A domain-specific, custom-trained large language model for the differential diagnosis and treatment planning of lymphedema, lipedema, and venous insufficiency.
Read the detailed description
The differential diagnosis of lower limb swelling remains problematic in clinical practice, as lymphedema, lipedema, and peripheral venous disease often present with similar features. Therefore, we developed LymphedemaGPT, a GPT-5-based clinical assistant designed to help practitioners navigate these diagnostic complexities.
LymphedemaGPT was designed to analyze structured patient data to extract clinical summaries, present possible diagnoses with percentage probabilities, create differential diagnosis tables, suggest additional diagnostic tests, and generate evidence-based treatment plans.
LymphedemaGPT's responses are based on seven scientific publications uploaded to the system, in addition to the Sleigh BC \& Manna B (2023) and Rockson approaches. Owing to this resource integration, the model can provide more reliable and consistent recommendations aligned with evidence-based medicine principles based on current guidelines and scientific publications.
Extensive prompt engineering techniques were applied to optimize the diagnostic and therapeutic accuracy of LymphedemaGPT.
The model is programmed to prioritize the questioning phase until a diagnosis is confirmed. In the initial responses, only structured anamnesis questions were asked, and after sufficient information was collected, systematic analysis and treatment planning were initiated. The response flow was designed as follows: (1) history collection, (2) preliminary assessment, (3) additional questioning (if necessary), and (4) systematic analysis and treatment planning when sufficient data were obtained.
The following patient data was presented to LymphedemaGPT in a structured format:
Demographic data: Age, gender, height, weight Medical history: Additional illnesses, medications used, habits (smoking, alcohol) Complaint characteristics: Time of onset, affected area, symptoms (pain, heaviness, numbness, tingling, stiffness, limited movement, weakness, etc.) Physical examination findings: Stemmer sign, swelling change with elevation, skin findings Medical history: History of infection, history of surgery, history of malignancy (radiotherapy, chemotherapy, lymph node dissection, type of cancer) Imaging: Doppler ultrasonography and lymphoscintigraphy results, if available
LymphedemaGPT was asked to respond in the following 12-part standard format: (1) Clinical Summary, (2) Possible Diagnoses (% probability), (3) Differential Diagnosis, (4) Recommended Diagnostic Tests, (5) Treatment Plan, (6) Patient Education and Follow-up, (7) Red Flags, (8) references, (9) Level of Evidence and Confidence Score, (10) Ethical Note, (11) Data Summary (JSON/CSV), and (12) Analysis Timestamp.
The performance of LymphedemaGPT was evaluated by experienced physicians based on the following eight criteria:
- Accuracy and adequacy of clinical summary
- Accuracy of primary diagnosis
- Accuracy of differential diagnosis table
- Appropriateness of recommended diagnostic tests
- Concordance of treatment plan with current guidelines
- Appropriateness of compression class/exercise-diet recommendations
- Adequacy of red flags
- Overall clinical utility
Each criterion was scored using a 5-point Likert scale: 5 = excellent/completely suitable, 4 = good/significantly suitable, 3 = moderate/partially suitable, 2 = poor/inadequate, and 1 = very poor/not suitable. The maximum score for each case was 40 (8 criteria × 5 points), and the minimum score was 8.
Two experienced physicians independently performed the evaluation. The evaluators were physical medicine and rehabilitation specialists experienced in the management of lymphedema and lipedema, and they independently performed the scoring.
- Conditions
- Lymphedema, Artificial Intelligence (AI)
- Being tested
- a domain-specific, custom-trained large language model for the differential diagnosis and treatment planning of lymphedema, lipedema, and venous insufficiency
- Keywords
- lymphedema, chat gpt, artificial intelligence
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a domain-specific, custom-trained large language model for the differential diagnosis and treatment planning of lymphedema, lipedema, and venous insufficiencyOther
LymphedemaGPT was designed to analyze structured patient data to extract clinical summaries, present possible diagnoses with percentage probabilities, create differential diagnosis tables, suggest additional diagnostic tests, and generate evidence-based treatment plans.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy rate
Percentage of cases where the primary diagnosis (most likely diagnosis) was correctly determined. The maximum percentage for each case was 100, and the minimum percentage was 0. Higher percentages mean a better outcome.
Measured: 1 hour
Treatment adequacy rate
Percentage of treatment recommendations consistent with current guidelines. The maximum percentage for each case was 100, and the minimum percentage was 0. Higher percentages mean a better outcome.
Measured: 1 hour
Average criterion score
Average Likert score of two evaluators for each criterion. The maximum score for each case was 40, and the minimum score was 8. higher scores mean a better outcome.
Measured: 1 hour
Secondary outcomes (1)
Overall performance score
Overall average of all criteria and cases. The maximum score for each case was 40, and the minimum score was 8. higher scores mean a better outcome.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for LymphedemaStudies 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
- Cross-sectional
- Enrolment
- 25 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yunus Emre Doğan, MD, Principal investigator, Istanbul Fatih Sultan Mehmet Training and Research HospitalFeyza Akan Begoğlu, MD, Study chair, Istanbul Fatih Sultan Mehmet Training and Research HospitalMesut Canlı, MD, Study chair, Istanbul Fatih Sultan Mehmet Training and Research Hospitalİlknur Aktaş, MD, Prof., Study chair, Istanbul Fatih Sultan Mehmet Training and Research HospitalFeyza Ünlü Özkan, MD, Prof., Study chair, Istanbul Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485465
- Sponsor's protocol ID
- FSMLYMPHEDEMA
- Acronym
- CDTL
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leypold T, Lingens LF, Beier JP, Boos AM. Integrating AI in Lipedema Management: Assessing the Efficacy of GPT-4 as a Consultation Assistant. Life (Basel). 2024 May 20;14(5):646. doi: 10.3390/life14050646.
PubMed 38792666Eldaly AS, Avila FR, Torres-Guzman RA, Maita K, Garcia JP, Serrano LP, Forte AJ. Artificial intelligence and lymphedema: State of the art. J Clin Transl Res. 2022 Jun 1;8(3):234-242. eCollection 2022 Jun 29.
PubMed 35813896Wojcik S, Rulkiewicz A, Pruszczyk P, Lisik W, Pobozy M, Domienik-Karlowicz J. Beyond ChatGPT: What does GPT-4 add to healthcare? The dawn of a new era. Cardiol J. 2023;30(6):1018-1025. doi: 10.5603/cj.97515. Epub 2023 Oct 13.
PubMed 37830256Mesko B. The Impact of Multimodal Large Language Models on Health Care's Future. J Med Internet Res. 2023 Nov 2;25:e52865. doi: 10.2196/52865.
PubMed 37917126
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Chat GPT in the Diagnosis and Treatment of Lymphedema
- ClinicalTrials.gov ID
- NCT07485465
- Acronym / sponsor ID
- CDTL / FSMLYMPHEDEMA
- Conditions
- Lymphedema, Artificial Intelligence (AI)
- Keywords
- lymphedema, chat gpt, artificial intelligence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 20 Mar 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.
A domain-specific, custom-trained large language model for the differential diagnosis and treatment planning of lymphedema, lipedema, and venous insufficiency.
Detailed description
The differential diagnosis of lower limb swelling remains problematic in clinical practice, as lymphedema, lipedema, and peripheral venous disease often present with similar features. Therefore, we developed LymphedemaGPT, a GPT-5-based clinical assistant designed to help practitioners navigate these diagnostic complexities.
LymphedemaGPT was designed to analyze structured patient data to extract clinical summaries, present possible diagnoses with percentage probabilities, create differential diagnosis tables, suggest additional diagnostic tests, and generate evidence-based treatment plans.
LymphedemaGPT's responses are based on seven scientific publications uploaded to the system, in addition to the Sleigh BC \& Manna B (2023) and Rockson approaches. Owing to this resource integration, the model can provide more reliable and consistent recommendations aligned with evidence-based medicine principles based on current guidelines and scientific publications.
Extensive prompt engineering techniques were applied to optimize the diagnostic and therapeutic accuracy of LymphedemaGPT.
The model is programmed to prioritize the questioning phase until a diagnosis is confirmed. In the initial responses, only structured anamnesis questions were asked, and after sufficient information was collected, systematic analysis and treatment planning were initiated. The response flow was designed as follows: (1) history collection, (2) preliminary assessment, (3) additional questioning (if necessary), and (4) systematic analysis and treatment planning when sufficient data were obtained.
The following patient data was presented to LymphedemaGPT in a structured format:
Demographic data: Age, gender, height, weight Medical history: Additional illnesses, medications used, habits (smoking, alcohol) Complaint characteristics: Time of onset, affected area, symptoms (pain, heaviness, numbness, tingling, stiffness, limited movement, weakness, etc.) Physical examination findings: Stemmer sign, swelling change with elevation, skin findings Medical history: History of infection, history of surgery, history of malignancy (radiotherapy, chemotherapy, lymph node dissection, type of cancer) Imaging: Doppler ultrasonography and lymphoscintigraphy results, if available
LymphedemaGPT was asked to respond in the following 12-part standard format: (1) Clinical Summary, (2) Possible Diagnoses (% probability), (3) Differential Diagnosis, (4) Recommended Diagnostic Tests, (5) Treatment Plan, (6) Patient Education and Follow-up, (7) Red Flags, (8) references, (9) Level of Evidence and Confidence Score, (10) Ethical Note, (11) Data Summary (JSON/CSV), and (12) Analysis Timestamp.
The performance of LymphedemaGPT was evaluated by experienced physicians based on the following eight criteria:
- Accuracy and adequacy of clinical summary
- Accuracy of primary diagnosis
- Accuracy of differential diagnosis table
- Appropriateness of recommended diagnostic tests
- Concordance of treatment plan with current guidelines
- Appropriateness of compression class/exercise-diet recommendations
- Adequacy of red flags
- Overall clinical utility
Each criterion was scored using a 5-point Likert scale: 5 = excellent/completely suitable, 4 = good/significantly suitable, 3 = moderate/partially suitable, 2 = poor/inadequate, and 1 = very poor/not suitable. The maximum score for each case was 40 (8 criteria × 5 points), and the minimum score was 8.
Two experienced physicians independently performed the evaluation. The evaluators were physical medicine and rehabilitation specialists experienced in the management of lymphedema and lipedema, and they independently performed the scoring.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- secondary lymphedema cases (post-pelvic surgery, post-breast cancer), primary lymphedema cases, lipedema cases (different types and stages), chronic venous insufficiency cases, mixed edema cases, and atypical presentations with diagnostic difficulties
Key inclusion criteria (4 listed)
- Patients over the age of 18
- Clinical diagnosis of lymphoedema
- Clinical diagnosis of lipoedema
- Clinical diagnosis of venous insufficiency
Key exclusion criteria (4 listed)
- Lack of medical history
- Lack of demographic data
- Lack of clinical data and
- Lack of imaging methods
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a domain-specific, custom-trained large language model for the differential diagnosis and treatment planning of lymphedema, lipedema, and venous insufficiencyLymphedemaGPT was designed to analyze structured patient data to extract clinical summaries, present possible diagnoses with percentage probabilities, create differential diagnosis tables, suggest additional diagnostic tests, and generate evidence-based treatment plans. | Other | – |
Primary outcome
Diagnostic accuracy rate
Time frame: 1 hour
Percentage of cases where the primary diagnosis (most likely diagnosis) was correctly determined. The maximum percentage for each case was 100, and the minimum percentage was 0. Higher percentages mean a better outcome.
Treatment adequacy rate
Time frame: 1 hour
Percentage of treatment recommendations consistent with current guidelines. The maximum percentage for each case was 100, and the minimum percentage was 0. Higher percentages mean a better outcome.
Average criterion score
Time frame: 1 hour
Average Likert score of two evaluators for each criterion. The maximum score for each case was 40, and the minimum score was 8. higher scores mean a better outcome.
1 secondary outcome
Overall performance score
Time frame: 1 hour
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 20 Mar 2026.
- Background: PubMed 38792666Leypold T, Lingens LF, Beier JP, Boos AM. Integrating AI in Lipedema Management: Assessing the Efficacy of GPT-4 as a Consultation Assistant. Life (Basel). 2024 May 20;14(5):646. doi: 10.3390/life14050646.
- Background: PubMed 35813896Eldaly AS, Avila FR, Torres-Guzman RA, Maita K, Garcia JP, Serrano LP, Forte AJ. Artificial intelligence and lymphedema: State of the art. J Clin Transl Res. 2022 Jun 1;8(3):234-242. eCollection 2022 Jun 29.
- Background: PubMed 37830256Wojcik S, Rulkiewicz A, Pruszczyk P, Lisik W, Pobozy M, Domienik-Karlowicz J. Beyond ChatGPT: What does GPT-4 add to healthcare? The dawn of a new era. Cardiol J. 2023;30(6):1018-1025. doi: 10.5603/cj.97515. Epub 2023 Oct 13.
- Background: PubMed 37917126Mesko B. The Impact of Multimodal Large Language Models on Health Care's Future. J Med Internet Res. 2023 Nov 2;25:e52865. doi: 10.2196/52865.
- Individual participant dataSharing planned: No
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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.
Yunus Emre Doğan, MD principal investigator
Istanbul Fatih Sultan Mehmet Training and Research Hospital
Feyza Akan Begoğlu, MD study chair
Istanbul Fatih Sultan Mehmet Training and Research Hospital
Mesut Canlı, MD study chair
Istanbul Fatih Sultan Mehmet 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 Lymphedema and Artificial Intelligence (AI), run by Fatih Sultan Mehmet 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 4 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: opening soon, as of the sponsor's last update on 20 Mar 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 Yunus Emre Doğan, MD (+90 506 051 25 00, ynsemredgn91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy rate (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07485465, which also lists 4 linked publications.
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 20 Mar 2026.