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AI-Driven Tumor Response Evaluation for Solid Tumors

NCT07685548 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 6120

Last updated 2026-07-08

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Observational Data Collection

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.

Sponsors & Collaborators

  • West China Hospital

    collaborator OTHER

  • Peking University Cancer Hospital & Institute

    collaborator OTHER

  • Sun Yat-Sen University Cancer Center

    collaborator OTHER

  • Fudan University

    collaborator OTHER

  • Shanghai Zhongshan Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2029-06-30
Completion
2029-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07685548 on ClinicalTrials.gov