Treatment Recommendations for Gastrointestinal Cancers Via Large Language Models
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinician-Directed Treatment Plan, ChatGPT-Assisted Treatment Plan.
- Who it may be relevant to
- Registry conditions: Gastrointestinal Neoplasm Malignant. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, China, Germany, Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Application of Large Language Models in the Recommendation of Treatment Plans for Gastrointestinal Cancers
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Influence Rate of ChatGPT on Treatment Plans [Time frame: Within 24 hours after the treatment plan is determined from the onset of study participation.]
Secondary outcome measures (1)
- 3-year Progression-Free Survival (PFS) Rate [Time frame: 3 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 4 centers
- Jiangmen Central Hospital — Jiangmen
- The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai
- Zhuhai People's Hospital — Zhuhai
- Peking University Cancer Hospital (Inner Mongolia Campus) — Hohhot
United States · 1 center
- City of Hope — Duarte
Germany · 1 center
- University Hospital Magdeburg — Magdeburg
Italy · 1 center
- San Raffaele University Hospital, Italy — Milan
Identifiers
NCT: NCT06002425 · CASMI006