An interventional study of Personalized Digital Outreach in Pulmonary Nodules, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Not yet recruiting. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Not applicable, Interventional, and Health services research
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:
Participants will:
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.
99 studies on the registry are indexed under Multiple Pulmonary Nodules; 42 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 97 across 46 interventional studies indexed under Multiple Pulmonary Nodules.
Browse Multiple Pulmonary Nodules studies →The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 167 studies on the registry; 69 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Personalized Digital Outreach
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.
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.
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.
Time frame: From randomization through 16 weeks (Day 112)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From randomization through 12 months
Histologic Type of Diagnosed Lung Cancers
Distribution of histologic types among participants with pathologically confirmed lung cancer.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through 12 months after randomization
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Guangzhou Medical University →