NCT06002425

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
4 countries

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Aug 2023Dec 2028

First Submitted

Initial submission to the registry

August 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

August 29, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Expected
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

1 month

First QC Date

August 13, 2023

Last Update Submit

September 6, 2023

Conditions

Keywords

Artificial IntelligenceLarge Language ModelGastrointestinal CancersTreatment Recommendation

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 24 hours after the treatment plan is determined from the onset of study participation.

Secondary Outcomes (1)

  • 3-year Progression-Free Survival (PFS) Rate

    3 years

Other Outcomes (1)

  • 5-year Overall Survival (OS) Rate

    5 years

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Other: Clinician-Directed Treatment Plan

GPT-Assisted Group

EXPERIMENTAL

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

Other: ChatGPT-Assisted Treatment Plan

Interventions

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.

Control group

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

GPT-Assisted Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

City of Hope

Duarte, California, 91010, United States

NOT YET RECRUITING

Jiangmen Central Hospital

Jiangmen, Guangdong, 529000, China

RECRUITING

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

RECRUITING

Zhuhai People's Hospital

Zhuhai, Guangdong, 519000, China

RECRUITING

Peking University Cancer Hospital (Inner Mongolia Campus)

Hohhot, Inner Mongolia, 010010, China

RECRUITING

University Hospital Magdeburg

Magdeburg, Saxony-Anhalt, 39120, Germany

NOT YET RECRUITING

San Raffaele University Hospital, Italy

Milan, 20132, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Di Dong, PhD

    Institute of Automation, Chinese Academy of Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 13, 2023

First Posted

August 21, 2023

Study Start

August 29, 2023

Primary Completion

September 30, 2023

Study Completion (Estimated)

December 31, 2028

Last Updated

September 8, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Data will become available 6 months after study completion and will remain available for a period of 5 years.
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.
More information

Locations