Gastrointestinal Neoplasm MalignantNCT06002425
Treatment Recommendations for Gastrointestinal Cancers Via Large Language Models
A study testing Clinician-Directed Treatment Plan and ChatGPT-Assisted Treatment Plan in people with Gastrointestinal Neoplasm Malignant, run by Chinese Academy of Sciences at 7 sites in 4 countries.
Trial summary
This study will evaluate the utility of ChatGPT in recommending treatment plans for patients with gastrointestinal cancers, using both retrospective and prospective data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasm Malignant
- What is being tested?
- Clinician-Directed Treatment Plan and ChatGPT-Assisted Treatment Plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 29 Aug 2023to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants with cancers other than gastrointestinal cancers.
- Participants who receive treatment in multiple hospitals.
Trial locations and contacts
7 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 4 countries
China4 sites, 4 recruiting
- Recruiting
Peking University Cancer Hospital (Inner Mongolia Campus)
Hohhot, Inner Mongolia, 010010
Xiaotian Zhang
Zhenghang Wang
- Recruiting
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000
Xiaobei Duan
- Recruiting
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000
Jing Pang
Guojie Wang
- Recruiting
Zhuhai People's Hospital
Zhuhai, Guangdong, 519000
Jie Zhang, Ph.D.
United States1 site, 1 recruiting
- Not yet recruiting
City of Hope
Duarte, California, 91010
Syed Rahmanuddin
Germany1 site, 1 recruiting
- Not yet recruiting
University Hospital Magdeburg
Magdeburg, Saxony-Anhalt, 39120
Michael Kreissl
Italy1 site, 1 recruiting
- Not yet recruiting
San Raffaele University Hospital, Italy
Milan, 20132
Diego Palumbo
About this study
Official title: Application of Large Language Models in the Recommendation of Treatment Plans for Gastrointestinal Cancers
This study will evaluate the utility of ChatGPT in recommending treatment plans for patients with gastrointestinal cancers, using both retrospective and prospective data.
Read the 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.
- Conditions
- Gastrointestinal Neoplasm Malignant
- Being tested
- Clinician-Directed Treatment Plan, ChatGPT-Assisted Treatment Plan
- Keywords
- Artificial Intelligence, Large Language Model, Gastrointestinal Cancers, Treatment Recommendation
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician-Directed Treatment PlanOther
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.
ChatGPT-Assisted Treatment PlanOther
In this approach, clinicians utilize the ChatGPT technological tool, formulating treatment plans for participants based on its suggestions and their own professional expertise.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | In this arm, participants receive treatment plans directly from clinicians without the assistance of ChatGPT. Receives: Other: Clinician-Directed Treatment Plan |
| GPT-Assisted Group | Experimental | In this arm, participants receive treatment plans from clinicians with the assistance of ChatGPT. Receives: Other: ChatGPT-Assisted Treatment Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Percentage of participants without disease progression over a period of 3 years from the start of treatment.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start29 Aug 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Neoplasm MalignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- 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
- Responsible party
- Principal investigator, Di Dong, Chinese Academy of Sciences
- Investigators
- Di Dong, PhD, Principal investigator, Institute of Automation, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002425
- Sponsor's protocol ID
- CASMI006
- Status last verified
- Sep 2023
- First submitted
- 13 Aug 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Large Language Models in the Recommendation of Treatment Plans for Gastrointestinal Cancers
- ClinicalTrials.gov ID
- NCT06002425
- Acronym / sponsor ID
- CASMI006
- Conditions
- Gastrointestinal Neoplasm Malignant
- Keywords
- Artificial Intelligence, Large Language Model, Gastrointestinal Cancers, Treatment Recommendation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chinese Academy of SciencesOther government
- 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
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Clinician-Directed Treatment PlanIn this arm, participants receive treatment plans directly from clinicians without the assistance of ChatGPT. |
| GPT-Assisted Group | Experimental | Other: ChatGPT-Assisted Treatment PlanIn this arm, participants receive treatment plans from clinicians with the assistance of ChatGPT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Participants with cancers other than gastrointestinal cancers.
- Participants who receive treatment in multiple hospitals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinician-Directed Treatment PlanIn 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 | Control group |
| ChatGPT-Assisted Treatment PlanIn this approach, clinicians utilize the ChatGPT technological tool, formulating treatment plans for participants based on its suggestions and their own professional expertise. | Other | GPT-Assisted Group |
Primary outcome
Influence Rate of ChatGPT on Treatment Plans
Time frame: Within 24 hours after the treatment plan is determined from the onset of study participation.
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.
1 secondary outcome
3-year Progression-Free Survival (PFS) Rate
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Di Dong, PhD principal investigator
Institute of Automation, Chinese Academy of Sciences
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinician-Directed Treatment Plan and ChatGPT-Assisted Treatment Plan in people with Gastrointestinal Neoplasm Malignant, run by Chinese Academy of Sciences at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China, United States, Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Di Dong, PhD (+86 13811833760, di.dong@ia.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence Rate of ChatGPT on Treatment Plans (time frame: Within 24 hours after the treatment plan is determined from the onset of study participation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.