Pulmonary NodulesNCT07805434
AI-Based Personalized Digital Management for High-Risk Pulmonary Nodule Follow-up
A study testing Personalized Digital Outreach in people with Pulmonary Nodules, run by The First Affiliated Hospital of Guangzhou Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Nodules
- What is being tested?
- Personalized Digital Outreach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: AI-Based Personalized Digital Management to Improve Follow-up Care Adherence Among Patients With High-Risk Pulmonary Nodules: A Pragmatic Randomized Clinical Trial
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:
Read more
- 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
- Being tested
- Personalized Digital Outreach
- Medical subject headings
- Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Digital OutreachBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Digital Management | Experimental | Following common AI-based identification, eligibility confirmation, and randomization, participants assigned to this arm will receive personalized information about their high-risk pulmonary nodule and recommendations for appropriate specialist follow-up through the hospital's official WeChat account. Participants will otherwise continue routine clinical care. Receives: Behavioral: Personalized Digital Outreach |
| Usual Care | No intervention | Participants assigned to this arm will not receive the study-specific personalized digital information or follow-up recommendations after randomization. They will continue routine clinical care. Standard clinical communication and any necessary safety notifications will remain available. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Nodule Follow-up Completion Within 16 Weeks After Randomization
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.
Measured: From randomization through 16 weeks (Day 112)
Secondary outcomes (14)
Follow-up Completion Within 30 Days After Randomization
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.
Measured: From randomization through 30 days
Time From Recommended Management Due Date to First Follow-up Completion
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.
Measured: From randomization through Day 112
Time From Index Chest CT to First Follow-up Completion
Days from the index chest CT to the first qualifying A-F event, described within prespecified 3-, 6-, or 12-month management strata.
Measured: From index chest CT through Day 112
Lung Cancer Diagnosis
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.
Measured: From randomization through 12 months
Diagnostic Closure
Proportion achieving malignant diagnosis, specific benign diagnosis, or adequate clinical evaluation documenting that no further diagnostic work-up is required.
Measured: From randomization through 12 months
Stage of Diagnosed Lung Cancers
Clinical and pathologic TNM stage distribution among diagnosed lung cancers, including the proportion diagnosed at stage I or II.
Measured: From randomization through 12 months
Histologic Type of Diagnosed Lung Cancers
Distribution of histologic types among participants with pathologically confirmed lung cancer.
Measured: From randomization through 12 months
Invasive Procedures Related to the Index Nodule
Proportion of all randomized participants undergoing bronchoscopy, percutaneous biopsy, surgical sampling or resection, or image-guided ablation related to the index nodule.
Measured: From randomization through 12 months
Complications Following an Invasive Procedure
Proportion of all randomized participants experiencing prespecified related complications, including pneumothorax, bleeding, infection, hospitalization, intensive care, or death.
Measured: From randomization through 12 months
Benign Biopsy
Proportion of all randomized participants undergoing tissue sampling with a final benign result and no lung cancer diagnosis during the prespecified follow-up.
Measured: From randomization through 12 months
Nondiagnostic Tissue Sampling
Proportion of all randomized participants undergoing tissue sampling that does not establish a malignant or specific benign diagnosis.
Measured: From randomization through 12 months
Time From Index Chest CT to Lung Cancer Diagnosis
Days from the index chest CT to the prespecified lung cancer diagnosis date.
Measured: From index chest CT through 12 months after randomization
Time From Randomization to Lung Cancer Diagnosis
Days from randomization to the prespecified lung cancer diagnosis date.
Measured: From randomization through 12 months
Time From Recommended Due Date to Lung Cancer Diagnosis
Difference in days between the prespecified management due date and lung cancer diagnosis; limited to participants with a valid due date.
Measured: Through 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary NodulesStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805434
- Sponsor's protocol ID
- LINC-LUNG-01
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Based Personalized Digital Management to Improve Follow-up Care Adherence Among Patients With High-Risk Pulmonary Nodules: A Pragmatic Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07805434
- Acronym / sponsor ID
- LINC-LUNG-01
- Conditions
- Pulmonary Nodules
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Digital Management | Experimental | Behavioral: Personalized Digital OutreachFollowing common AI-based identification, eligibility confirmation, and randomization, participants assigned to this arm will receive personalized information about their high-risk pulmonary nodule and recommendations for appropriate specialist follow-up through the hospital's official WeChat account. Participants will otherwise continue routine clinical care. |
| Usual Care | No intervention | –Participants assigned to this arm will not receive the study-specific personalized digital information or follow-up recommendations after randomization. They will continue routine clinical care. Standard clinical communication and any necessary safety notifications will remain available. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Digital OutreachShortly 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. | Behavioural | Personalized Digital Management |
Primary outcome
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.
14 secondary outcomes
Follow-up Completion Within 30 Days After Randomization
Time frame: From randomization through 30 days
Time From Recommended Management Due Date to First Follow-up Completion
Time frame: From randomization through Day 112
Time From Index Chest CT to First Follow-up Completion
Time frame: From index chest CT through Day 112
Lung Cancer Diagnosis
Time frame: From randomization through 12 months
Diagnostic Closure
Time frame: From randomization through 12 months
Stage of Diagnosed Lung Cancers
Time frame: From randomization through 12 months
Histologic Type of Diagnosed Lung Cancers
Time frame: From randomization through 12 months
Invasive Procedures Related to the Index Nodule
Time frame: From randomization through 12 months
Complications Following an Invasive Procedure
Time frame: From randomization through 12 months
Benign Biopsy
Time frame: From randomization through 12 months
Nondiagnostic Tissue Sampling
Time frame: From randomization through 12 months
Time From Index Chest CT to Lung Cancer Diagnosis
Time frame: From index chest CT through 12 months after randomization
Time From Randomization to Lung Cancer Diagnosis
Time frame: From randomization through 12 months
Time From Recommended Due Date to Lung Cancer Diagnosis
Time frame: Through 12 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Digital Outreach in people with Pulmonary Nodules, run by The First Affiliated Hospital of Guangzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Nodule Follow-up Completion Within 16 Weeks After Randomization (time frame: From randomization through 16 weeks (Day 112)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.