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NCT Number: NCT07805434

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

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.

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Key information

Conditions

Pulmonary Nodules Lung Diseases Lung Neoplasms Multiple Pulmonary Nodules Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 40 years or older.
  • Completion of a chest CT at the study hospital for clinical care, health examination, or another reason.
  • At least one pulmonary nodule classified as high risk by the Linc model, with a predicted malignancy probability of 75% or greater. The index CT, index nodule, model version, and risk score must be traceable.
  • Follow-up management for the index nodule has not been completed before randomization, and the participant has not entered a clearly documented active pulmonary nodule management pathway.
  • Ability to provide valid electronic informed consent and receive study messages through the hospital's official WeChat account.

Exclusion criteria

  • Prior or current lung cancer, or ongoing diagnostic evaluation, treatment, postoperative care, or surveillance for the index nodule.
  • Active malignancy for which the pulmonary nodule should be evaluated or managed as possible metastatic disease or within another established cancer care pathway.
  • Completion before randomization of a qualifying chest CT, pulmonary nodule specialist or multidisciplinary team evaluation, PET/CT, tissue sampling, surgery or lesion-directed treatment, or verified clinical closure related to the index nodule.
  • An existing valid order, appointment, referral, or documented active management plan for the index nodule, including active management by thoracic surgery, a pulmonary nodule clinic or multidisciplinary team, oncology, or radiation oncology.
  • Maximum diameter of the index lesion greater than 30 mm. These patients will receive standardized safety notification and accelerated specialist referral and will not be randomized.
  • Lung-RADS category 4B or 4X, or an equivalent highly suspicious finding, when Lung-RADS is applicable or can be reliably reconstructed, if clinical safety review determines that immediate notification or accelerated clinical care is required.
  • Another major clinical safety, ethical, technical, or data-protection concern that cannot be reasonably mitigated.

Treatment and study plan

Personalized Digital Outreach

Behavioral

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.

Primary outcomes

  1. Pulmonary Nodule Follow-up Completion Within 16 Weeks After Randomization

    Time frame: From randomization through 16 weeks (Day 112)

    The proportion of all randomized participants who complete at least one qualifying pulmonary nodule follow-up event by Day 112. Qualifying events include: (1) chest CT related to the index nodule; (2) pulmonary nodule specialist or multidisciplinary team evaluation with a documented assessment and management plan; (3) PET/CT; (4) bronchoscopy, percutaneous biopsy, or other tissue sampling; (5) surgery, image-guided ablation, or lesion-directed radiotherapy; or (6) documented clinical closure by a qualified clinician after adequate evaluation. Orders or appointments alone do not count. Patient refusal, loss to follow-up, or death alone do not constitute clinical closure. The denominator includes all randomized participants analyzed according to assigned group. Only hospital records or verified outside-hospital records count as completion.

Secondary outcomes

  1. Follow-up Completion Within 30 Days After Randomization

    Time frame: From randomization through 30 days

    Proportion of all randomized participants completing at least one qualifying A-F follow-up event, using the same event and evidence rules as the primary outcome.

  2. Time From Recommended Management Due Date to First Follow-up Completion

    Time frame: From randomization through Day 112

    Difference in days between the first qualifying follow-up event and the prespecified due date. Negative values indicate early completion; positive values indicate delay. Limited to participants with a valid due date.

  3. Time From Index Chest CT to First Follow-up Completion

    Time frame: From index chest CT through Day 112

    Days from the index chest CT to the first qualifying A-F event, described within prespecified 3-, 6-, or 12-month management strata.

  4. Lung Cancer Diagnosis

    Time frame: From randomization through 12 months

    Proportion of all randomized participants meeting the prespecified lung cancer diagnosis standard. Pathologic confirmation is preferred; adjudicated clinical diagnosis is permitted when prespecified criteria are met.

  5. Diagnostic Closure

    Time frame: From randomization through 12 months

    Proportion achieving malignant diagnosis, specific benign diagnosis, or adequate clinical evaluation documenting that no further diagnostic work-up is required.

  6. Stage of Diagnosed Lung Cancers

    Time frame: From randomization through 12 months

    Clinical and pathologic TNM stage distribution among diagnosed lung cancers, including the proportion diagnosed at stage I or II.

  7. Histologic Type of Diagnosed Lung Cancers

    Time frame: From randomization through 12 months

    Distribution of histologic types among participants with pathologically confirmed lung cancer.

  8. Invasive Procedures Related to the Index Nodule

    Time frame: From randomization through 12 months

    Proportion of all randomized participants undergoing bronchoscopy, percutaneous biopsy, surgical sampling or resection, or image-guided ablation related to the index nodule.

  9. Complications Following an Invasive Procedure

    Time frame: From randomization through 12 months

    Proportion of all randomized participants experiencing prespecified related complications, including pneumothorax, bleeding, infection, hospitalization, intensive care, or death.

  10. Benign Biopsy

    Time frame: From randomization through 12 months

    Proportion of all randomized participants undergoing tissue sampling with a final benign result and no lung cancer diagnosis during the prespecified follow-up.

  11. Nondiagnostic Tissue Sampling

    Time frame: From randomization through 12 months

    Proportion of all randomized participants undergoing tissue sampling that does not establish a malignant or specific benign diagnosis.

  12. Time From Index Chest CT to Lung Cancer Diagnosis

    Time frame: From index chest CT through 12 months after randomization

    Days from the index chest CT to the prespecified lung cancer diagnosis date.

  13. Time From Randomization to Lung Cancer Diagnosis

    Time frame: From randomization through 12 months

    Days from randomization to the prespecified lung cancer diagnosis date.

  14. Time From Recommended Due Date to Lung Cancer Diagnosis

    Time frame: Through 12 months after randomization

    Difference in days between the prespecified management due date and lung cancer diagnosis; limited to participants with a valid due date.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study title

AI-Based Personalized Digital Management to Improve Follow-up Care Adherence Among Patients With High-Risk Pulmonary Nodules: A Pragmatic Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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