Dynamic Evolution of Pulmonary Nodules and Influence Factors of Its Clinical Decision-making

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-12-31

Brief Summary

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The researchers are aimed to investigate the dynamic evolution of indeterminate pulmonary nodules by a long-term follow-up of patients with different characteristics. Influence factors of clinical decision-making that might contribute to overtreatment or delayed treatment will also be studied.

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Detailed Description

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This observatory study prospectively recruits patients with indeterminate pulmonary nodules identified in computed tomography (CT) scans from thoracic clinic. The radiological features and their chronological changes during follow-up period will be recorded in detail. Subgroup analyses will be performed based on the clinical and demographic characteristics of patients (including symptomatic information, comorbidities, family history, antibiotic usage, etc). Hospital Anxiety and Depression Scale (HADS) is collected from each patient at multiple time points to evaluate the patients' psychological status and its impact on clinical decision-making. The interaction analyses between individual characteristics (such as education level, occupation, disease cognitive level, etc) and Hospital Anxiety and Depression Scale will also be performed. The researchers aim to provide high-quality evidence for the formulation of a precise follow-up and management plan for patients with pulmonary nodules.

Conditions

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Pulmonary Nodule, Solitary Pulmonary Nodule, Multiple

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pulmonary Nodule

Patients are recommended for using antibiotics, solely follow-up or surgical resection according to the current clinical guideline for management of indeterminate pulmonary nodule. No intervention is administered for this observatory study.

CT scan

Intervention Type DIAGNOSTIC_TEST

For patients with low-risk pulmonary nodules, follow-up CT scan is recommended

Antibiotics

Intervention Type DRUG

For pulmonary nodules with features of infectious disease, antibiotics is recommended

Surgical Resection

Intervention Type PROCEDURE

For persistent high-risk pulmonary nodules, surgical resection is recommended

Interventions

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CT scan

For patients with low-risk pulmonary nodules, follow-up CT scan is recommended

Intervention Type DIAGNOSTIC_TEST

Antibiotics

For pulmonary nodules with features of infectious disease, antibiotics is recommended

Intervention Type DRUG

Surgical Resection

For persistent high-risk pulmonary nodules, surgical resection is recommended

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients with pulmonary nodules ≤ 3cm
2. Patients who provide electronic, written or oral consent to be enrolled in the follow-up cohort

Exclusion Criteria

1. Patients with a surgical history of pulmonary nodules;
2. Patients who have obtained pathological diagnosis through surgery or non-surgical methods such as puncture;
3. Patients with pulmonary nodules that are likely metastatic from other sites;
4. Refuse to participate in this study.

Minimum Eligible Age

14 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes