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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Dynamic Evolution of Pulmonary Nodules and Influence Factors of Its Clinical Decision-making: A Prospective Cohort Study

Conditions
-----------------
Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple

Intervention / Treatment
-----------------
* Diagnostic Test: CT scan
* Drug: Antibiotics
* Procedure: Surgical Resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pulmonary nodules ≤ 3cm Patients who provide electronic, written or oral consent to be enrolled in the follow-up cohort Exclusion Criteria: Patients with a surgical history of pulmonary nodules; Patients who have obtained pathological diagnosis through surgery or non-surgical methods such as puncture; Patients with pulmonary nodules that are likely metastatic from other sites; Refuse to participate in this study.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pulmonary Nodule<br>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. | Diagnostic Test: CT scan<br>* For patients with low-risk pulmonary nodules, follow-up CT scan is recommended<br>Drug: Antibiotics<br>* For pulmonary nodules with features of infectious disease, antibiotics is recommended<br>Procedure: Surgical Resection<br>* For persistent high-risk pulmonary nodules, surgical resection is recommended<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to surgical resection | Time calculated from the date of identification of pulmonary nodule to the date of surgical resection | The date of first documented diagnosis of pulmonary nodule by CT scan to the date of surgical resection, up to 60 months | 
| Time to progression | Time calculated from the date of identification of pulmonary nodule to the date of progression of pulmonary nodule based on evaluation of CT imaging | The date of first documented diagnosis of pulmonary nodule by CT scan to the date of documented progression by CT scan, up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of malignancy | Proportion of malignant findings by pathological examination in all patients receiving surgical resection | The date of first documented diagnosis of pulmonary nodule by CT scan to the date of surgical resection, up to 60 months | 
| Change of Hospital Anxiety and Depression Scale-Anxiety (HADS-A) score | The differences of Hospital Anxiety and Depression Scale-Anxiety (HADS-A) scores of the same patients before and after surgical resection. This 7-item checklist is a part of the Hospital Anxiety and Depression Scale, which is used for assessment for the status of anxiety. The maximal score for HADS-A is 21. Scores of greater than or equal to 11 on either scale indicate a definitive case. Scores of 0-7 are defined to be normal, while scores of 8-10 are defined to be borderline abnormal (borderline case). | The date of enrollment in our cohort study when Hospital Anxiety and Depression Scale is measured to the date when primary endpoint( surgical resection) is reached, up to 60 months, with multiple measurements. | 
| Change of Hospital Anxiety and Depression Scale-Depression (HADS-D) score | The differences of Hospital Anxiety and Depression Scale-Depression (HADS-D) scores of the same patients before and after surgical resection. This 7-item checklist is a part of the Hospital Anxiety and Depression Scale, which is used for assessment for the status of depression. The maximal score for HADS-D is 21. Scores of greater than or equal to 11 on either scale indicate a definitive case. Scores of 0-7 are defined to be normal, while scores of 8-10 are defined to be borderline abnormal (borderline case). | The date of enrollment in our cohort study when Hospital Anxiety and Depression Scale is measured to the date when primary endpoint( surgical resection) is reached, up to 60 months, with multiple measurements. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary nodule, Radiologic picture, Prospective observatory study, Psychological state, Decision-making