AI-Based Personalized Digital Management for High-Risk Pulmonary Nodule Follow-up
2026年9月1日 更新者：Jianxing He、The First Affiliated Hospital of Guangzhou Medical University
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:
- 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.
調査の概要
研究の種類
介入
入学 (推定)
4000
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Personalized Digital Management
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.
|
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.
|
|
介入なし：Usual Care
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pulmonary Nodule Follow-up Completion Within 16 Weeks After Randomization
時間枠：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.
|
From randomization through 16 weeks (Day 112)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Follow-up Completion Within 30 Days After Randomization
時間枠：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.
|
From randomization through 30 days
|
|
Time From Recommended Management Due Date to First Follow-up Completion
時間枠：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.
|
From randomization through Day 112
|
|
Time From Index Chest CT to First Follow-up Completion
時間枠：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.
|
From index chest CT through Day 112
|
|
Lung Cancer Diagnosis
時間枠：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.
|
From randomization through 12 months
|
|
Diagnostic Closure
時間枠：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.
|
From randomization through 12 months
|
|
Stage of Diagnosed Lung Cancers
時間枠：From randomization through 12 months
|
Clinical and pathologic TNM stage distribution among diagnosed lung cancers, including the proportion diagnosed at stage I or II.
|
From randomization through 12 months
|
|
Histologic Type of Diagnosed Lung Cancers
時間枠：From randomization through 12 months
|
Distribution of histologic types among participants with pathologically confirmed lung cancer.
|
From randomization through 12 months
|
|
Invasive Procedures Related to the Index Nodule
時間枠：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.
|
From randomization through 12 months
|
|
Complications Following an Invasive Procedure
時間枠：From randomization through 12 months
|
Proportion of all randomized participants experiencing prespecified related complications, including pneumothorax, bleeding, infection, hospitalization, intensive care, or death.
|
From randomization through 12 months
|
|
Benign Biopsy
時間枠：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.
|
From randomization through 12 months
|
|
Nondiagnostic Tissue Sampling
時間枠：From randomization through 12 months
|
Proportion of all randomized participants undergoing tissue sampling that does not establish a malignant or specific benign diagnosis.
|
From randomization through 12 months
|
|
Time From Index Chest CT to Lung Cancer Diagnosis
時間枠：From index chest CT through 12 months after randomization
|
Days from the index chest CT to the prespecified lung cancer diagnosis date.
|
From index chest CT through 12 months after randomization
|
|
Time From Randomization to Lung Cancer Diagnosis
時間枠：From randomization through 12 months
|
Days from randomization to the prespecified lung cancer diagnosis date.
|
From randomization through 12 months
|
|
Time From Recommended Due Date to Lung Cancer Diagnosis
時間枠：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.
|
Through 12 months after randomization
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2027年4月1日
研究の完了 (推定)
2028年10月1日
試験登録日
最初に提出
2026年9月1日
QC基準を満たした最初の提出物
2026年9月1日
最初の投稿 (実際)
2026年9月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月4日
QC基準を満たした最後の更新が送信されました
2026年9月1日
最終確認日
2026年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。