Treatment Recommendations for Gastrointestinal Cancers Via Large Language Models

September 6, 2023 updated by: Di Dong, Chinese Academy of Sciences

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Jiangmen, Guangdong, China, 529000
        • Recruiting
        • Jiangmen Central Hospital
        • Contact:
          • Xiaobei Duan
      • Zhuhai, Guangdong, China, 519000
        • Recruiting
        • The Fifth Affiliated Hospital of Sun Yat-sen University
        • Contact:
          • Jing Pang
        • Contact:
          • Guojie Wang
      • Zhuhai, Guangdong, China, 519000
        • Recruiting
        • Zhuhai People's Hospital
        • Contact:
          • Jie Zhang, Ph.D.
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010010
        • Recruiting
        • Peking University Cancer Hospital (Inner Mongolia Campus)
        • Contact:
          • Xiaotian Zhang
        • Contact:
          • Zhenghang Wang
  • Germany
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Germany, 39120
        • Not yet recruiting
        • University Hospital Magdeburg
        • Contact:
          • Michael Kreissl
  • Italy
      • Milan, Italy, 20132
        • Not yet recruiting
        • San Raffaele University Hospital, Italy
        • Contact:
          • Diego Palumbo
  • United States
    • California
      • Duarte, California, United States, 91010
        • Not yet recruiting
        • City of Hope
        • Contact:
          • Syed Rahmanuddin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control group
In this arm, participants receive treatment plans directly from clinicians without the assistance of ChatGPT.
Other: Clinician-Directed Treatment Plan
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.
Experimental: GPT-Assisted Group
In this arm, participants receive treatment plans from clinicians with the assistance of ChatGPT.
Other: ChatGPT-Assisted Treatment Plan
In this approach, clinicians utilize the ChatGPT technological tool, formulating treatment plans for participants based on its suggestions and their own professional expertise.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Within 24 hours after the treatment plan is determined from the onset of study participation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
3 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese Academy of Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
City of Hope Medical Center
Fifth Affiliated Hospital, Sun Yat-Sen University
ZhuHai Hospital
Jiangmen Central Hospital
San Raffaele University Hospital, Italy
Peking University Cancer Hospital (Inner Mongolia Campus)
University Hospital Magdeburg, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Di Dong, PhD, Institute of Automation, Chinese Academy of Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 29, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CASMI006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) may be made available to other researchers upon request. Interested researchers should present a reasonable research proposal and a data usage application. All participating units of this study will review and assess the proposal and application to determine whether to share the data.

IPD Sharing Time Frame

Data will become available 6 months after study completion and will remain available for a period of 5 years.

IPD Sharing Access Criteria

Interested researchers should submit a detailed research proposal and a data usage application for review. All participating units of this study will assess the application to determine eligibility for data access.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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