Gastric CancerNCT07746830
Prospective Assessment of Alignment Between Multimodal Artificial Intelligence and Multidisciplinary Team Decisions in Gastrointestinal Oncology
An observational study of Gastric Cancer and Colorectal Cancer, run by Shanghai Minimally Invasive Surgery Center at 1 site in China.
Trial summary
This prospective, single-center observational study will evaluate the concordance between a multimodal artificial intelligence system and multidisciplinary team decisions in patients with gastrointestinal tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Colorectal Cancer, Gastrointestinal Cancer
- What is being tested?
- Multidisciplinary Team Clinical Decision Assessment and Multimodal Artificial Intelligence-Based Clinical Decision Assessment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2026to 5 Aug 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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
Study population: Consecutive adult patients with suspected or confirmed gastric, colon, or rectal cancer who are scheduled for multidisciplinary team evaluation at Ruijin Hospital because of a clinical question related to diagnosis, staging, perioperative treatment, surgical planning, recurrence or metastasis, conversion therapy, response assessment, or another complex management decision. Eligible participants must have an identifiable clinical decision time point and sufficient clinical information to permit paired evaluation by the multimodal artificial intelligence system and the multidisciplinary team.
Who may be able to join
- Aged 18 years or older, with no restriction based on sex.
- Histologically confirmed gastric, colon, or rectal cancer; or highly suspected gastric, colon, or rectal malignancy based on clinical, endoscopic, or imaging findings, with further diagnostic, staging, or treatment planning required.
- Scheduled for multidisciplinary team evaluation at the study center because of an initial diagnosis, clinical staging, perioperative treatment, surgical planning, recurrence or metastasis, conversion therapy, treatment response assessment, or another complex clinical management question.
- A clearly identifiable clinical decision time point can be established, and the clinical information available before that time point can be defined.
- At the clinical decision time point, at least the basic medical history, the clinical question to be addressed, and at least one core source of information from endoscopy, pathology, or imaging are available. Completion of all examinations is not required, because missing examinations may be evaluated as part of diagnostic task planning.
- A corresponding multidisciplinary team recommendation regarding diagnostic tasks or the principal treatment decision can be obtained for comparison with the artificial intelligence output.
- Willing and able to understand the study and provide dated written informed consent.
Who cannot join
- Further examination confirms a condition other than gastric, colon, or rectal cancer, and the case is not applicable to the gastrointestinal oncology pathways evaluated in this study.
- The participant is undergoing routine follow-up or continuation of a previously established treatment plan and has no clinical question requiring additional diagnostic tasks, modification of the principal treatment pathway, or multidisciplinary team decision-making.
- A clear clinical decision time point cannot be established, or information available before and after the decision cannot be distinguished, preventing comparison of the artificial intelligence system and the multidisciplinary team under the same information conditions.
- Core clinical information is severely incomplete, such that the current stage of care and the clinical question cannot be identified and a clinically meaningful artificial intelligence output cannot be generated.
- A clear multidisciplinary team recommendation corresponding to the clinical decision time point cannot be obtained, or the multidisciplinary team documentation is insufficient for paired evaluation.
- The participant requires immediate resuscitation or urgent clinical management, and study recruitment could interfere with necessary medical care.
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- The participant is unable to provide valid informed consent because of impaired consciousness, severe cognitive impairment, or another reason, and no ethics-approved proxy consent procedure is available for this study.
- The participant declines research use of the medical record, endoscopic, pathological, imaging, or other required clinical data.
- Any other condition that, in the investigator's judgment, could seriously affect participant rights, data compliance, or the reliability of the study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin hospital Shanghai Jiaotong University, School of Medicine
Shanghai, Shanghai Municipality, 200025
Jing Sun, MD, PhD, +86-13524284622, sj11788@rjh.com.cn
About this study
This prospective, single-center observational study will evaluate the concordance between a multimodal artificial intelligence system and multidisciplinary team decisions in patients with gastrointestinal tumors. For each enrolled case, the AI system and the MDT will independently review the same available clinical information, including medical history, laboratory findings, imaging, pathology, and other relevant diagnostic data, and will generate recommendations regarding diagnosis, staging, treatment planning, and further examinations. An independent expert panel will assess the agreement, clinical appropriateness, and potential major errors of the two decision pathways. AI-generated recommendations will be used solely for research evaluation and will not directly influence patient care. The study aims to determine the feasibility, reliability, and safety of multimodal AI-assisted decision-making in real-world gastrointestinal oncology workflows.
- Conditions
- Gastric Cancer, Colorectal Cancer, Gastrointestinal Cancer
- Being tested
- Multidisciplinary Team Clinical Decision Assessment, Multimodal Artificial Intelligence-Based Clinical Decision Assessment
- Keywords
- Colorectal Cancer, Gastric Cancer, MDT, Artificial Intelligence
- Medical subject headings
- Stomach Neoplasms, Colorectal Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary Team Clinical Decision AssessmentOther
Using the same clinical information available at the predefined decision time point, the institutional multidisciplinary team will independently formulate recommendations regarding diagnosis, staging, additional examinations, and treatment planning according to routine clinical practice. Clinical management will remain under the responsibility of the treating physicians and the multidisciplinary team. The MDT decision and the independently generated AI output will subsequently be compared and evaluated by an independent expert panel.
Multimodal Artificial Intelligence-Based Clinical Decision AssessmentOther
Available clinical information for each enrolled participant, including medical history, laboratory findings, endoscopic findings, imaging, pathology, and molecular testing results when available, will be entered into a multimodal artificial intelligence system. The system will independently generate a structured assessment of diagnosis, staging, additional diagnostic tasks, and treatment planning. The AI-generated output will be recorded solely for research comparison, will not be disclosed to the treating multidisciplinary team before its decision is finalized, and will not directly influence patient care.
| Study group | Role | What they receive |
|---|---|---|
| Patients With Gastrointestinal Tumors | Participants with gastric, colon, or rectal tumors who are prospectively enrolled and undergo parallel, independent clinical decision assessments by a multimodal artificial intelligence system and a multidisciplinary team using the same clinical information available at the predefined decision time point. AI-generated recommendations are used solely for research evaluation and do not directly influence clinical care. Receives: Other: Multidisciplinary Team Clinical Decision Assessment; Other: Multimodal Artificial Intelligence-Based Clinical Decision Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Acceptability Concordance Rate Between the Multimodal Artificial Intelligence System and the Multidisciplinary Team
The proportion of evaluable participants whose AI-generated diagnostic task plan and principal treatment recommendation are judged by an independent expert panel to be fully concordant with the MDT decision or a clinically acceptable alternative. Results will be reported as a percentage with a 95% confidence interval.
Measured: At the predefined index clinical decision point, within 28 days after enrollment
Secondary outcomes (3)
Full Concordance Rate
The proportion of evaluable participants whose AI-generated diagnostic task plan and principal treatment recommendation are judged to be fully concordant with the MDT decision.
Measured: At the predefined index clinical decision point, within 28 days after enrollment
Major Discordance Rate
The proportion of evaluable participants whose AI-generated recommendation is judged to contain a major discordance with potential for clinically significant harm.
Measured: At the predefined index clinical decision point, within 28 days after enrollment
Successful AI Output Rate
The proportion of enrolled participants for whom the AI system successfully generates an evaluable diagnostic task plan and principal treatment recommendation.
Measured: At the predefined index clinical decision point, within 28 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start5 Aug 2026 (estimated)
- Primary completion5 Aug 2027 (estimated)
- Study completion5 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Jin, Shanghai Minimally Invasive Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746830
- Sponsor's protocol ID
- GI-ALIGN
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data because the study involves sensitive clinical records, medical images, and digital pathology data with potential re-identification risks. Aggregate study results will be reported.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Alignment Between Multimodal Artificial Intelligence and Multidisciplinary Team Decisions in Gastrointestinal Oncology
- ClinicalTrials.gov ID
- NCT07746830
- Acronym / sponsor ID
- GI-ALIGN
- Conditions
- Gastric Cancer, Colorectal Cancer, Gastrointestinal Cancer
- Keywords
- Colorectal Cancer, Gastric Cancer, MDT, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Study start
- 5 Aug 2026 (estimated)
- Primary completion
- 5 Aug 2027 (estimated)
- Study completion
- 5 Aug 2028 (estimated)
- First posted
- 5 Aug 2026 (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 prospective, single-center observational study will evaluate the concordance between a multimodal artificial intelligence system and multidisciplinary team decisions in patients with gastrointestinal tumors. For each enrolled case, the AI system and the MDT will independently review the same available clinical information, including medical history, laboratory findings, imaging, pathology, and other relevant diagnostic data, and will generate recommendations regarding diagnosis, staging, treatment planning, and further examinations. An independent expert panel will assess the agreement, clinical appropriateness, and potential major errors of the two decision pathways. AI-generated recommendations will be used solely for research evaluation and will not directly influence patient care. The study aims to determine the feasibility, reliability, and safety of multimodal AI-assisted decision-making in real-world gastrointestinal oncology workflows.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Gastrointestinal Tumors | – | Other: Multidisciplinary Team Clinical Decision Assessment, Other: Multimodal Artificial Intelligence-Based Clinical Decision AssessmentParticipants with gastric, colon, or rectal tumors who are prospectively enrolled and undergo parallel, independent clinical decision assessments by a multimodal artificial intelligence system and a multidisciplinary team using the same clinical information available at the predefined decision time point. AI-generated recommendations are used solely for research evaluation and do not directly influence clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients with suspected or confirmed gastric, colon, or rectal cancer who are scheduled for multidisciplinary team evaluation at Ruijin Hospital because of a clinical question related to diagnosis, staging, perioperative treatment, surgical planning, recurrence or metastasis, conversion therapy, response assessment, or another complex management decision. Eligible participants must have an identifiable clinical decision time point and sufficient clinical information to permit paired evaluation by the multimodal artificial intelligence system and the multidisciplinary team.
Key inclusion criteria (7 listed)
- Aged 18 years or older, with no restriction based on sex.
- Histologically confirmed gastric, colon, or rectal cancer; or highly suspected gastric, colon, or rectal malignancy based on clinical, endoscopic, or imaging findings, with further diagnostic, staging, or treatment planning required.
- Scheduled for multidisciplinary team evaluation at the study center because of an initial diagnosis, clinical staging, perioperative treatment, surgical planning, recurrence or metastasis, conversion therapy, treatment response assessment, or another complex clinical management question.
- A clearly identifiable clinical decision time point can be established, and the clinical information available before that time point can be defined.
- At the clinical decision time point, at least the basic medical history, the clinical question to be addressed, and at least one core source of information from endoscopy, pathology, or imaging are available. Completion of all examinations is not required, because missing examinations may be evaluated as part of diagnostic task planning.
Key exclusion criteria (9 listed)
- Further examination confirms a condition other than gastric, colon, or rectal cancer, and the case is not applicable to the gastrointestinal oncology pathways evaluated in this study.
- The participant is undergoing routine follow-up or continuation of a previously established treatment plan and has no clinical question requiring additional diagnostic tasks, modification of the principal treatment pathway, or multidisciplinary team decision-making.
- A clear clinical decision time point cannot be established, or information available before and after the decision cannot be distinguished, preventing comparison of the artificial intelligence system and the multidisciplinary team under the same information conditions.
- Core clinical information is severely incomplete, such that the current stage of care and the clinical question cannot be identified and a clinically meaningful artificial intelligence output cannot be generated.
- A clear multidisciplinary team recommendation corresponding to the clinical decision time point cannot be obtained, or the multidisciplinary team documentation is insufficient for paired evaluation.
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 |
|---|---|---|
| Multidisciplinary Team Clinical Decision AssessmentUsing the same clinical information available at the predefined decision time point, the institutional multidisciplinary team will independently formulate recommendations regarding diagnosis, staging, additional examinations, and treatment planning according to routine clinical practice. Clinical management will remain under the responsibility of the treating physicians and the multidisciplinary team. The MDT decision and the independently generated AI output will subsequently be compared and evaluated by an independent expert panel. | Other | Patients With Gastrointestinal Tumors |
| Multimodal Artificial Intelligence-Based Clinical Decision AssessmentAvailable clinical information for each enrolled participant, including medical history, laboratory findings, endoscopic findings, imaging, pathology, and molecular testing results when available, will be entered into a multimodal artificial intelligence system. The system will independently generate a structured assessment of diagnosis, staging, additional diagnostic tasks, and treatment planning. The AI-generated output will be recorded solely for research comparison, will not be disclosed to the treating multidisciplinary team before its decision is finalized, and will not directly influence patient care. | Other | Patients With Gastrointestinal Tumors |
Primary outcome
Clinical Acceptability Concordance Rate Between the Multimodal Artificial Intelligence System and the Multidisciplinary Team
Time frame: At the predefined index clinical decision point, within 28 days after enrollment
The proportion of evaluable participants whose AI-generated diagnostic task plan and principal treatment recommendation are judged by an independent expert panel to be fully concordant with the MDT decision or a clinically acceptable alternative. Results will be reported as a percentage with a 95% confidence interval.
3 secondary outcomes
Full Concordance Rate
Time frame: At the predefined index clinical decision point, within 28 days after enrollment
Major Discordance Rate
Time frame: At the predefined index clinical decision point, within 28 days after enrollment
Successful AI Output Rate
Time frame: At the predefined index clinical decision point, within 28 days after enrollment
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 5 Aug 2026.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data because the study involves sensitive clinical records, medical images, and digital pathology data with potential re-identification risks. Aggregate study results will be reported.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Colorectal Cancer, run by Shanghai Minimally Invasive Surgery Center at 1 site in China.
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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 Jing Sun, MD, PhD (+86-13524284622, sj11788@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Acceptability Concordance Rate Between the Multimodal Artificial Intelligence System and the Multidisciplinary Team (time frame: At the predefined index clinical decision point, within 28 days after enrollment). 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 5 Aug 2026.