Treatment Recommendations for Gastrointestinal Cancers Via Large Language Models

Chinese Academy of Sciences

Status: Enrolling

Conditions: Gastrointestinal Neoplasm Malignant

Treatments: Other: ChatGPT-Assisted Treatment Plan; Other: Clinician-Directed Treatment Plan

Study type: Interventional

Funder types: Other

Identifiers

NCT06002425

CASMI006

Details and patient eligibility

About

This study will evaluate the utility of ChatGPT in recommending treatment plans for patients with gastrointestinal cancers, using both retrospective and prospective data.

Full description

The medical records of over 1,200 patients with gastrointestinal cancers will be collected retrospectively from participating hospitals. This data will be split into an exploratory dataset (n=200) and a validation dataset (n>=1,000). Within the exploratory dataset, various prompt methods will be used to determine the treatment plans suggested by ChatGPT. Additionally, several clinicians of varied seniority levels will provide their treatment recommendations. For the validation dataset, ChatGPT's suggestions for treatment plans will undergo both qualitative and quantitative assessments by a multidisciplinary consultation (MDT) team. The recommendations from ChatGPT will then be compared with those from the clinicians.

Furthermore, this study will incorporate a prospective dataset comprising 400 participants with gastrointestinal cancers. The participants will be randomly allocated to either a control group (n=200) or a ChatGPT-Assisted group (n=200). In the control group, treatment plan recommendations will solely be provided by the clinicians and will guide subsequent treatments. In the ChatGPT-Assisted group, initial treatment plan recommendations will be independently proposed by both ChatGPT and the clinicians. Based on ChatGPT's suggestions, clinicians might selectively adjust their initial plans. Participants will then receive treatments as per these refined plans. Within the ChatGPT-Assisted group, the treatment plans of the initial 100 participants will be evaluated to determine the percentage of patients whose treatment plans are influenced by ChatGPT. Subsequently, the proportion of participants in the entire ChatGPT-Assisted group with treatment plans modified by ChatGPT will be calculated. The study will further monitor the 3-year progression-free survival (PFS) and the 5-year overall survival (OS) rates, contrasting the outcomes between the control and ChatGPT-assisted groups.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years, both male and female.
• Pathologically confirmed diagnosis of gastrointestinal cancer (gastric cancer or colorectal Cancer).
• Detailed medical records available prior to treatment (including chief complaint, history of present illness, radiological examinations, pathological examinations, laboratory tests, etc.).
• Participants will receive complete treatment in the participating hospitals.

Exclusion criteria

• Participants with cancers other than gastrointestinal cancers.
• Participants who receive treatment in multiple hospitals.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Control group

Active Comparator group

Description:

In this arm, participants receive treatment plans directly from clinicians without the assistance of ChatGPT.

Treatment:

Other: Clinician-Directed Treatment Plan

GPT-Assisted Group

Experimental group

Description:

In this arm, participants receive treatment plans from clinicians with the assistance of ChatGPT.

Treatment:

Other: ChatGPT-Assisted Treatment Plan