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NCT07741058Enrolling by invitation

AI-Augmented Diagnostic Assessment With ENLIGHT Versus Independent Pathologist Review

Source: ClinicalTrials.gov · Last updated 3 Aug 2026

Brief summary (registry, in English)

This study will evaluate whether artificial intelligence (AI) can enhance clinicians' accuracy, efficiency, and confidence in distinguishing lung adenocarcinoma (LUAD) from lung squamous cell carcinoma (LUSC) and kidney renal papillary cell carcinoma (KIRP) from kidney renal clear cell carcinoma (KIRC) using digitized pathology slides. These subtype classifications are routinely performed by pathologists but can be challenging and time-consuming, particularly in difficult cases. During the study, participating clinicians will review lung and kidney pathology slides under three different conditions: * Unaided Review: Diagnosis without AI assistance. * AI as Double-Check: The clinician first makes an independent diagnosis, after which the AI-generated diagnosis (prediction only or prediction with explanation) is revealed for review. * AI as First-Look: The AI-generated diagnosis (prediction only or prediction with explanation) is presented before the clinician begins the review. Clinicians will be randomly assigned to different review sequences to minimize potential order effects. This study design will enable us to assess the impact of AI assistance on diagnostic accuracy, interpretation time, and clinician confidence.

Status (registry)
Enrolling by invitation
Study type
Interventional
Enrollment
25 (estimated)
First submitted
28 Jul 2026
Start date
Jul 2026
Primary completion date
Aug 2026
Lead sponsor
Harvard Medical School (HMS and HSDM)
NCT number
NCT07741058

What you commit to

  • Study type: Interventional
  • Planned participants: 25
  • From Jul 2026 to the primary completion date, Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Poor-quality or unreadable slides
  • Cases used in AI training

Who the study is looking for

  • Hematoxylin and eosin (H\&E)-stained pathology slides
  • Final diagnosis confirmed through molecular testing in conjunction with expert pathology evaluation
  • Board-certified or board-eligible pathologists
  • Willingness to complete both unaided and AI-assisted review sessions

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Harvard Medical School
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.