Treatment Recommendations for Gastrointestinal Cancers Via Large Language Models

NCT ID: NCT06002425

Last Updated: 2023-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-29

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastrointestinal Neoplasm Malignant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

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

Group Type ACTIVE_COMPARATOR

Clinician-Directed Treatment Plan

Intervention Type 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.

GPT-Assisted Group

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

Group Type EXPERIMENTAL

ChatGPT-Assisted Treatment Plan

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ZhuHai Hospital

OTHER

Sponsor Role collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Jiangmen Central Hospital

OTHER

Sponsor Role collaborator

Peking University Cancer Hospital (Inner Mongolia Campus)

UNKNOWN

Sponsor Role collaborator

San Raffaele University Hospital, Italy

OTHER

Sponsor Role collaborator

University Hospital Magdeburg, Germany

UNKNOWN

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role collaborator

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Di Dong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Di Dong, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Automation, Chinese Academy of Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

City of Hope

Duarte, California, United States

Site Status NOT_YET_RECRUITING

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Site Status RECRUITING

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

Site Status RECRUITING

Zhuhai People's Hospital

Zhuhai, Guangdong, China

Site Status RECRUITING

Peking University Cancer Hospital (Inner Mongolia Campus)

Hohhot, Inner Mongolia, China

Site Status RECRUITING

University Hospital Magdeburg

Magdeburg, Saxony-Anhalt, Germany

Site Status NOT_YET_RECRUITING

San Raffaele University Hospital, Italy

Milan, , Italy

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States China Germany Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Di Dong, PhD

Role: CONTACT

+86 13811833760

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Syed Rahmanuddin

Role: primary

Xiaobei Duan

Role: primary

Jing Pang

Role: primary

Guojie Wang

Role: backup

Jie Zhang, Ph.D.

Role: primary

Xiaotian Zhang

Role: primary

Zhenghang Wang

Role: backup

Michael Kreissl

Role: primary

Diego Palumbo

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CASMI006

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Bioinformation Therapy for Gastric Cancer
NCT03350477 COMPLETED PHASE2/PHASE3