Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasms, Unknown Primary

Neoplasm Metastasis

Neoplastic Processes

These patients with cancer of unknown primary received site-specific therapy that matched the particular site predicted by the DNA methylation classifier.

These patients with cancer of unknown primary received empirical therapy that didn't match the particular site predicted by the DNA methylation classifier.

Yiyang Zhang

This study aims to initially utilize machine learning on pan-cancer DNA methylation data from public databases to construct a DNA methylation classification model (PaCIFiC-CUP, pan-cancer integrated fingerprinting classifier of CUP) for diagnosing various types of cancer, particularly the primary site of cancer of unknown primary. The goal is to achieve diagnosis of cancer pathology type by analyzing the DNA methylation patterns of cancer specimens, thereby guiding subsequent precision treatment for cancer.

PaCIFiC-CUP Classifies Cancer of Unknown Primary

PaCIFiC-CUP：Pan-Cancer Integrated Fingerprinting Classifier for Identifying the Origin of Cancer of Unknown Primary: A Multi-Center Bidirectional Cohort Study

Overall survival refers to the length of time that a person lives after being diagnosed with cancer of unknown primary, without regard to any specific cause of death.

Progression-Free Survival refers to the length of time during which a patient with cancer of unknown primary remains alive without any signs or symptoms of disease progression

First People's Hospital of Foshan

Third Affiliated Hospital, Sun Yat-Sen University

The First Affiliated Hospital of Anhui Medical University

Anhui Provincial Cancer Hospital

Dongguan People's Hospital

Beijing Tongren Hospital

Anhui Provincial Hospital

Peking University Third Hospital

Henan Cancer Hospital

Ganzhou Cancer Hospital

Guangzhou Chest Hospital.

First Affiliated Hospital of Jinan University

Peking University Shenzhen Hospital

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Sun Yat-sen University

Principal Investigator

Digestive System Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

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.

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.

Clinician-Directed 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.

ChatGPT-Assisted Treatment Plan

Di Dong, PhD

Syed Rahmanuddin

Xiaobei Duan

Jing Pang

Guojie Wang

Jie Zhang, Ph.D.

Xiaotian Zhang

Zhenghang Wang

Michael Kreissl

Diego Palumbo

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

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.

Treatment Recommendations for Gastrointestinal Cancers Via Large Language Models

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

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.

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

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PaCIFiC-CUP Classifies Cancer of Unknown Primary	NCT06140992	Unknown Primary... DNA Methylation		18 Years - 80 Years	Sun Yat-sen University
PaCIFiC-CUP Classifies Cancer of Unknown Primary	NCT06140992	Unknown Primary... DNA Methylation		18 Years - 80 Years	Sun Yat-sen University
Treatment Recommendations for Gastrointestinal Cancers Via Large Language Models	NCT06002425	Gastrointestina...	Clinician-Direc... ChatGPT-Assiste...	18 Years -	Chinese Academy of Sciences

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