Treatment Recommendations for Gastrointestinal Cancers Via Large Language Models

Not Applicable

Recruiting

• Conditions: Gastrointestinal Neoplasm Malignant
• Interventions: Other: ChatGPT-Assisted Treatment Plan; Other: Clinician-Directed Treatment Plan

• Registration Number: NCT06002425
• Lead Sponsor: Chinese Academy of Sciences

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-08-13
• Study First Submitted QC: 2023-08-13
• Study First Posted: 2023-08-21
• Study Start: 2023-08-29
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-08
• Primary Completion: 2023-09-30
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GPT-Assisted Group	ChatGPT-Assisted Treatment Plan	In this arm, participants receive treatment plans from clinicians with the assistance of ChatGPT.
Control group	Clinician-Directed Treatment Plan	In this arm, participants receive treatment plans directly from clinicians without the assistance of ChatGPT.

Primary Outcome Measures

Name	Time	Method
Influence Rate of ChatGPT on Treatment Plans	Within 24 hours after the treatment plan is determined from the onset of study participation.	The percentage of the initial 100 participants and the overall participants in the ChatGPT-Assisted group whose treatment plans are adjusted by clinicians after consulting with ChatGPT.

Secondary Outcome Measures

Name	Time	Method
3-year Progression-Free Survival (PFS) Rate	3 years	Percentage of participants without disease progression over a period of 3 years from the start of treatment.

Trial Locations

Locations (7)

Peking University Cancer Hospital (Inner Mongolia Campus); 🇨🇳 Hohhot, Inner Mongolia, China

City of Hope; 🇺🇸 Duarte, California, United States

Jiangmen Central Hospital; 🇨🇳 Jiangmen, Guangdong, China

The Fifth Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Zhuhai, Guangdong, China

Zhuhai People's Hospital; 🇨🇳 Zhuhai, Guangdong, China

University Hospital Magdeburg; 🇩🇪 Magdeburg, Saxony-Anhalt, Germany

San Raffaele University Hospital, Italy; 🇮🇹 Milan, Italy