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Treatment Recommendations for Gastrointestinal Cancers Via Large Language Models

Primary Purpose

Gastrointestinal Neoplasm Malignant

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Clinician-Directed Treatment Plan
ChatGPT-Assisted Treatment Plan
Sponsored by
Chinese Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Neoplasm Malignant focused on measuring Artificial Intelligence, Large Language Model, Gastrointestinal Cancers, Treatment Recommendation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • City of Hope
  • Jiangmen Central HospitalRecruiting
  • The Fifth Affiliated Hospital of Sun Yat-sen UniversityRecruiting
  • Zhuhai People's HospitalRecruiting
  • Peking University Cancer Hospital (Inner Mongolia Campus)Recruiting
  • University Hospital Magdeburg
  • San Raffaele University Hospital, Italy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

GPT-Assisted Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Influence Rate of ChatGPT on Treatment Plans
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

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

Full Information

First Posted
August 13, 2023
Last Updated
September 6, 2023
Sponsor
Chinese Academy of Sciences
Collaborators
ZhuHai Hospital, 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, City of Hope Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT06002425
Brief Title
Treatment Recommendations for Gastrointestinal Cancers Via Large Language Models
Official Title
Application of Large Language Models in the Recommendation of Treatment Plans for Gastrointestinal Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 29, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Sciences
Collaborators
ZhuHai Hospital, 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, City of Hope Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Neoplasm Malignant
Keywords
Artificial Intelligence, Large Language Model, Gastrointestinal Cancers, Treatment Recommendation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
In this arm, participants receive treatment plans directly from clinicians without the assistance of ChatGPT.
Arm Title
GPT-Assisted Group
Arm Type
Experimental
Arm Description
In this arm, participants receive treatment plans from clinicians with the assistance of ChatGPT.
Intervention Type
Other
Intervention Name(s)
Clinician-Directed Treatment Plan
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
ChatGPT-Assisted Treatment Plan
Intervention Description
In this approach, clinicians utilize the ChatGPT technological tool, formulating treatment plans for participants based on its suggestions and their own professional expertise.
Primary Outcome Measure Information:
Title
Influence Rate of ChatGPT on Treatment Plans
Description
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.
Time Frame
Within 24 hours after the treatment plan is determined from the onset of study participation.
Secondary Outcome Measure Information:
Title
3-year Progression-Free Survival (PFS) Rate
Description
Percentage of participants without disease progression over a period of 3 years from the start of treatment.
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
5-year Overall Survival (OS) Rate
Description
Percentage of participants who are still alive over a period of 5 years from the start of treatment.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Di Dong, PhD
Phone
+86 13811833760
Email
di.dong@ia.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Di Dong, PhD
Organizational Affiliation
Institute of Automation, Chinese Academy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Syed Rahmanuddin
Facility Name
Jiangmen Central Hospital
City
Jiangmen
State/Province
Guangdong
ZIP/Postal Code
529000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaobei Duan
Facility Name
The Fifth Affiliated Hospital of Sun Yat-sen University
City
Zhuhai
State/Province
Guangdong
ZIP/Postal Code
519000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Pang
First Name & Middle Initial & Last Name & Degree
Guojie Wang
Facility Name
Zhuhai People's Hospital
City
Zhuhai
State/Province
Guangdong
ZIP/Postal Code
519000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Zhang, Ph.D.
Facility Name
Peking University Cancer Hospital (Inner Mongolia Campus)
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaotian Zhang
First Name & Middle Initial & Last Name & Degree
Zhenghang Wang
Facility Name
University Hospital Magdeburg
City
Magdeburg
State/Province
Saxony-Anhalt
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Kreissl
Facility Name
San Raffaele University Hospital, Italy
City
Milan
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Palumbo

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.radiomics.net.cn/

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Treatment Recommendations for Gastrointestinal Cancers Via Large Language Models

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