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

Active, not recruiting

• Conditions: Pulmonary Nodule, Multiple; Pulmonary Nodule, Solitary
• Interventions: Diagnostic Test: CT scan; Drug: Antibiotics; Procedure: Surgical Resection

• Registration Number: NCT04857333
• Lead Sponsor: GuiBin Qiao

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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-23
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-16
• Primary Completion: 2023-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1800

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pulmonary Nodule	Antibiotics	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.
Pulmonary Nodule	CT scan	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.
Pulmonary Nodule	Surgical Resection	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.

Primary Outcome Measures

Name	Time	Method
Time to 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 calculated from the date of identification of pulmonary nodule to the date of surgical resection
Time to progression	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	Time calculated from the date of identification of pulmonary nodule to the date of progression of pulmonary nodule based on evaluation of CT imaging

Secondary Outcome Measures

Name	Time	Method
Proportion of malignancy	The date of first documented diagnosis of pulmonary nodule by CT scan to the date of surgical resection, up to 60 months	Proportion of malignant findings by pathological examination in all patients receiving surgical resection
Change of Hospital Anxiety and Depression Scale-Anxiety (HADS-A) score	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.	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).
Change of Hospital Anxiety and Depression Scale-Depression (HADS-D) score	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.	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).

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China