- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07626736
Evaluating the Efficacy and Safety of AI Localization Models in Multidisciplinary Team Care for NSCLC
Evaluating the Efficacy and Safety of AI Localization Models in Multidisciplinary Team Care for NSCLC: a Prospective, Controlled Clinical Trial Protocol
The goal of this clinical trial is to evaluate the effectiveness and safety of a locally deployed artificial intelligence (AI) decision-support model in the multidisciplinary team (MDT) process for patients with non-small cell lung cancer (NSCLC).
The main questions it aims to answer :
What is the level of agreement between treatment recommendations generated by the AI model and those made by a traditional MDT? How often do clinicians modify their final treatment decision after reviewing the AI model's recommendation? Researchers will compare treatment plans from the traditional MDT (Arm 1), the AI model (Arm 2), and the clinician's final decision after reviewing the AI output (Arm 3) to assess consistency, decision modification rates, and clinical efficiency.
Participants will:
Have their clinical, imaging, and molecular data submitted to both the traditional MDT and the AI model for independent treatment recommendations Receive a final treatment plan determined by clinicians after reviewing both recommendations, with follow-up for safety and survival outcomes
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: qing liang, Dr.
- 전화번호: +86 17863321987
- 이메일: liangtsing99@163.com
연구 장소
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Guangdong
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Guangzhou, Guangdong, 중국, 510000
- 모병
- Guangdong Provincial People's Hospital
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연락하다:
- Wenzhao Zhong, Dr.
- 전화번호: +8613609777314
- 이메일: 13609777314@163.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age ≥ 18 years;
- MDT (Multidisciplinary Team) discussion deems a systemic treatment plan necessary;
- Complete clinical, imaging, and molecular pathological data.
Exclusion Criteria:
- Stage I patients;
- Diagnosed with a thoracic tumor other than NSCLC;
- Lack of detailed medical data, or missing data;
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: AI-Assisted Multidisciplinary Team Decision-Making for Non-Small Cell Lung Cancer
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The impact of artificial intelligence on clinicians' treatment plans
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Consistency rate
기간: Baseline(MDT 1 Day)
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Consistency rate between Option 1 and Option 2 (calculated using Kappa value).
Consistency rate between Option 1 and Option 3 (decision modification rate).
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Baseline(MDT 1 Day)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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MDT Discussion Process Time
기간: Baseline(MDT Day 1)
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Time from start to end of multidisciplinary team (MDT) discussion, measured immediately after MDT end.
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Baseline(MDT Day 1)
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Quality of AI Recommendations
기간: Baseline(MDT Day 1)
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Physician-rated quality of AI recommendations using a Likert 5-point scale (1 = very poor, 5 = excellent).
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Baseline(MDT Day 1)
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Clinical Acceptability of AI
기간: Baseline(MDT Day 1)
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Physician-rated clinical acceptability of AI recommendations using a Likert 5-point scale (1 = unacceptable, 5 = fully acceptable).
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Baseline(MDT Day 1)
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MDT Discussion Efficiency
기간: Baseline(MDT Day 1)
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Physician-rated efficiency of MDT discussion process aided by AI using a Likert 5-point scale (1 = very inefficient, 5 = very efficient).
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Baseline(MDT Day 1)
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Process Convenience
기간: Baseline(MDT Day 1)
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Physician-rated convenience of the AI-integrated workflow using a Likert 5-point scale (1 = very inconvenient, 5 = very convenient).
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Baseline(MDT Day 1)
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Added Value to Clinical Decision
기간: Baseline(MDT Day 1)
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Physician-rated added value of AI to clinical decision-making using a Likert 5-point scale (1 = no added value, 5 = significant added value).
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Baseline(MDT Day 1)
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Learning and Training Value
기간: Baseline(MDT Day 1)
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Physician-rated learning and training value of AI system using a Likert 5-point scale (1 = no value, 5 = high value).
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Baseline(MDT Day 1)
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Overall Satisfaction
기간: Baseline(MDT Day 1)
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Physician-rated overall satisfaction with AI-assisted MDT using a Likert 5-point scale (1 = very dissatisfied, 5 = very satisfied).
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Baseline(MDT Day 1)
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Willingness to Use in Future
기간: Baseline(MDT Day 1)
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Physician-rated willingness to use AI system in future clinical practice using a Likert 5-point scale (1 = definitely not willing, 5 = definitely willing).
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Baseline(MDT Day 1)
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Disease-Free Survival (DFS)
기간: 3 years
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Time from treatment initiation to disease recurrence or death from any cause, assessed every 3-6 months during 2-3 years follow-up.
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3 years
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Progression-Free Survival (PFS)
기간: 3 years
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Time from treatment initiation to disease progression or death from any cause, assessed every 3-6 months during 2-3 years follow-up.
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3 years
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Overall Survival (OS)
기간: 3 years
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Time from treatment initiation to death from any cause, assessed every 3-6 months during 2-3 years follow-up.
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3 years
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Pillay B, Wootten AC, Crowe H, Corcoran N, Tran B, Bowden P, Crowe J, Costello AJ. The impact of multidisciplinary team meetings on patient assessment, management and outcomes in oncology settings: A systematic review of the literature. Cancer Treat Rev. 2016 Jan;42:56-72. doi: 10.1016/j.ctrv.2015.11.007. Epub 2015 Nov 24.
- Kim JK, Chua ME, Li TG, Rickard M, Lorenzo AJ. Novel AI applications in systematic review: GPT-4 assisted data extraction, analysis, review of bias. BMJ Evid Based Med. 2025 Sep 22;30(5):313-322. doi: 10.1136/bmjebm-2024-113066.
- Wiegand TLT, Jung LB, Gudera JA, Schuhmacher LS, Moehrle P, Rischewski JF, Mehrzad P, Jeong S, Nguyen LH, Poeschla M, Velezmoro LI, Kruk L, Dimitriadis K, Koerte IK. Demographic inaccuracies and biases in the depiction of patients by artificial intelligence text-to-image generators. NPJ Digit Med. 2025 Jul 19;8(1):459. doi: 10.1038/s41746-025-01817-6.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- KY2025-1003-02
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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