AI-Driven Tumor Response Evaluation for Solid Tumors

NCT07685548 | Not Yet Recruiting

• 1 other identifier: AIRECIST-001
• Study Type: observational
• Target: 6,120
• Locations: 0 countries
• Sites: N/A

Brief 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

Neoplasms; Hepatocellular Carcinoma; Solid Tumor Cancer

Keywords

Artificial Intelligence; Tumor Response Evaluation

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Time from treatment initiation to death from any cause or last follow-up. OS is an objective, clinically meaningful endpoint that directly reflects treatment efficacy and patient prognosis.

  From treatment initiation until death or last follow-up, assessed up to 36 months

Secondary Outcomes (4)

• Progression-Free Survival (PFS)

  From treatment initiation until disease progression or death, assessed up to 36 months

• Tumor Volume Change Rate

  Baseline and at each follow-up imaging time point (e.g., 4-8 weeks, 3 months, 6 months, 12 months post-treatment), assessed up to 36 months

• Change in Number of Lesions

  Baseline and at each follow-up imaging time point, assessed up to 36 months

• Appearance of New Lesions

  At each follow-up imaging time point, assessed up to 36 months

Other Outcomes (3)

• AI Model Performance - Concordance Index (C-index)

  At study completion, assessed up to 36 months

• AI Model Performance - Time-Dependent ROC AUC

  At study completion, assessed up to 36 months

• Physician Workflow Efficiency - Reading Time

  During the human-machine collaboration evaluation, assessed up to 36 months

Study Arms (2)

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.

Other: Observational Data Collection

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.

Other: Observational Data Collection

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.

Prospective Cohort; Retrospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This multi-center retrospective-prospective cohort study includes adult patients (≥18 years) with radiologically or pathologically confirmed solid tumors who have received or are receiving non-surgical treatment. The retrospective cohort comprises approximately 6,000 patients treated between January 2015 and December 2025, with complete imaging, clinical, laboratory, and molecular data from multiple centers across China. The prospective cohort consists of approximately 120 patients consecutively enrolled from 2026 onward, with data collected in real-world clinical settings. Participants are excluded if imaging quality is insufficient for AI-based analysis, key clinical or follow-up data are missing, or they have concurrent malignancies that cannot be distinguished from the primary tumor. The study population reflects the diversity of solid tumor types and treatment patterns in routine clinical practice.

You may qualify if:

• Age ≥ 18 years, any sex.
• Radiologically or pathologically confirmed diagnosis of solid tumor.
• Received non-surgical treatment with a clearly defined treatment start date.
• Availability of baseline and at least one follow-up imaging study (CT/MRI) of sufficient quality for AI-based segmentation and volumetric analysis.
• Availability of key clinical data and follow-up outcome information.
• For retrospective cohort: prior signed informed consent for biobank donation, agreeing to donate samples and data for medical research.
• For prospective cohort: planned to receive or currently receiving non-surgical treatment, and able to provide written informed consent.

You may not qualify if:

• Imaging data incomplete or of insufficient quality for accurate segmentation or volumetric calculation.
• Key clinical information or follow-up outcome data missing.
• Treatment start or baseline time point cannot be clearly determined.
• Concurrent other malignancy that cannot be distinguished from the primary study tumor.
• Severe underlying diseases (e.g., cardiac, pulmonary, renal insufficiency) that may significantly affect survival outcome assessment.
• Cognitive impairment or other conditions that prevent cooperation with study procedures.
• For prospective cohort: expected inability to complete follow-up.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• West China Hospital: collaborator
• Sun Yat-Sen University Cancer Center: collaborator
• Fudan University: collaborator
• Peking University Cancer Hospital & Institute: collaborator

MeSH Terms

Conditions

Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: July 8, 2026

Record last verified: 2026-07