AI-Driven Tumor Response Evaluation for Solid Tumors

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT07685548
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Observational Data Collection — OTHER
    This is an observational study. No interventions are assigned. Data are collected from routine clinical imaging (CT/MRI), medical records, and laboratory tests as part of standard clinical care.

Study Details

Purpose: This study is developing and validating an artificial intelligence (AI)-driven system to evaluate tumor response using changes in total tumor volume. The goal is to determine whether this AI-based approach can better predict patient survival compared with the current standard method (RECIST), which relies on linear measurements of a few selected tumors. Participants: The study includes both retrospective and prospective cohorts. The retrospective cohort includes approximately 6,000 patients with solid tumors who received non-surgical treatment between 2015 and 2025. The prospective cohort will enroll approximately 120 patients starting in mid-2026. Study details include: Study Duration: Approximately 3 years Participation Duration: Up to 6 months for prospective participants; retrospective participants contribute existing medical records only Visit Frequency: For prospective participants, follow-up visits occur every 3 months (up to 6 months) aligned with routine clinical care Intervention: None. This is an observational study using routine clinical imaging (CT/MRI) and medical records Primary endpoints: Overall survival (OS) and progression-free survival (PFS). The study will also evaluate the feasibility and impact of AI-assisted tumor response reporting on clinical workflow and patient understanding. Participants in the prospective cohort will receive either a standard RECIST report or an AI-assisted dynamic tumor response report. This comparison is for research purposes only and does not alter standard medical care.

Key Dates

First listed
Jul 6, 2026
Start date
Jul 1, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
6,120 participants (estimated)

Arms

  • Arm: Retrospective Cohort
    Approximately 6,000 patients with solid tumors who received non-surgical treatment between January 2015 and December 2025. Data are collected from existing medical records, imaging archives (CT/MRI), and laboratory databases, with no additional interventions or procedures. This cohort is used for AI model training and internal validation.
  • Arm: Prospective Cohort
    Approximately 120 patients with solid tumors consecutively enrolled from 2026 onward. Data are collected prospectively in real-world clinical settings using an EDC system, including imaging, clinical, laboratory, and molecular data. Participants undergo standard-of-care imaging and follow-up; no study-specific interventions are assigned. This cohort is used for independent external validation of the AI model and assessment of clinical feasibility and patient experience.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From treatment initiation until death or last follow-up, assessed up to 36 months ]

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