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AI-Based Personalized Digital Management for High-Risk Pulmonary Nodule Follow-up

NCT07805434 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2026-09-04

No results posted yet for this study

Summary

The goal of this pragmatic clinical trial is to learn whether AI-based personalized digital management can help patients with high-risk pulmonary nodules complete appropriate follow-up care. The study will include adults aged 40 years or older whose pulmonary nodules were identified on chest CT scans already performed at the hospital for clinical care, health examinations, or other reasons. The hospital's AI-based lung nodule evaluation system will be used to identify nodules classified as high risk. Patients who have already completed follow-up or entered an active pulmonary nodule management pathway will not be included.

The main question this study aims to answer is:

\- Does personalized digital management increase the proportion of patients who complete appropriate pulmonary nodule follow-up within 16 weeks after randomization compared with usual care?

Researchers will compare personalized digital management with usual care. Participants will be randomly assigned in a 1:1 ratio to one of the following groups:

* The personalized digital management group will receive individualized information about the pulmonary nodule and recommendations for appropriate follow-up through the hospital's official WeChat account.
* The usual care group will not receive the study-specific personalized digital message. Participants in both groups may continue to receive routine clinical care.

Participants will:

* Provide electronic informed consent
* Answer a brief questionnaire about pulmonary nodule care received outside the hospital and selected health information, including smoking history
* Continue their usual medical care
* Allow researchers to review relevant hospital records to determine whether pulmonary nodule follow-up was completed

The study will not arrange an additional initial chest CT solely for research purposes. Appropriate follow-up may include specialist evaluation, follow-up chest CT, PET/CT, tissue sampling, surgery, or a documented clinical decision that no further evaluation is needed. Researchers will also examine subsequent diagnostic procedures, lung cancer diagnoses, treatments, complications, and longer-term clinical outcomes.

Conditions

  • Pulmonary Nodules

Interventions

BEHAVIORAL

Personalized Digital Outreach

Shortly after randomization, participants receive a study-specific personalized digital message through the hospital's official WeChat account. The message provides understandable information about the participant's AI-classified high-risk pulmonary nodule, explains that a high-risk classification does not establish a diagnosis of lung cancer, and recommends returning to a pulmonary nodule-related specialist for further evaluation. Subsequent imaging, diagnostic procedures, treatment, or observation will be determined by the treating clinician using the official radiology report, prior imaging, and the participant's clinical condition. Message delivery, opening, link clicks, and technical delivery failures will be recorded.

Sponsors & Collaborators

  • The First Affiliated Hospital of Guangzhou Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-04-01
Completion
2028-10-01

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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 NCT07805434 on ClinicalTrials.gov