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NCT Number: NCT06002425

Treatment Recommendations for Gastrointestinal Cancers Via Large Language Models

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

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Key information

Conditions

Gastrointestinal Neoplasm Malignant Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jiangmen Central Hospital, Jiangmen, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinician-Directed Treatment Plan

Other

In this approach, clinicians do not employ any technological assistance and rely solely on their professional expertise and experience to formulate treatment plans for participants.

ChatGPT-Assisted Treatment Plan

Other

In this approach, clinicians utilize the ChatGPT technological tool, formulating treatment plans for participants based on its suggestions and their own professional expertise.

Primary outcomes

  1. Influence Rate of ChatGPT on Treatment Plans

    Time frame: 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 outcomes

  1. 3-year Progression-Free Survival (PFS) Rate

    Time frame: 3 years

    Percentage of participants without disease progression over a period of 3 years from the start of treatment.

Other outcomes

  1. 5-year Overall Survival (OS) Rate

    Time frame: 5 years

    Percentage of participants who are still alive over a period of 5 years from the start of treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Di Dong, PhD

CONTACT

[email protected]

+86 13811833760

Sponsors and collaborators

Lead sponsor

Chinese Academy of Sciences

Other Gov

Collaborators

  • City of Hope Medical Center
  • Fifth Affiliated Hospital, Sun Yat-Sen University
  • Jiangmen Central Hospital
  • Peking University Cancer Hospital (Inner Mongolia Campus)
  • San Raffaele University Hospital, Italy
  • University Hospital Magdeburg, Germany
  • ZhuHai Hospital

Registry information

Official study title

Application of Large Language Models in the Recommendation of Treatment Plans for Gastrointestinal Cancers

Important dates

Study start
2023
Primary completion
2023
Study completion
2028
First posted
Aug 21, 2023
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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