NCT04857333

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,800 (actual)
• Sponsor: GuiBin Qiao · Academic / Other
• Sex: All
• Age: 14 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pulmonary Nodule, Solitary
• Pulmonary Nodule, Multiple

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CT scan	For patients with low-risk pulmonary nodules, follow-up CT scan is recommended
DRUG	Antibiotics	For pulmonary nodules with features of infectious disease, antibiotics is recommended
PROCEDURE	Surgical Resection	For persistent high-risk pulmonary nodules, surgical resection is recommended

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-12-31
• Completion: 2025-12-31
• First posted: 2021-04-23
• Last updated: 2023-03-16

Locations

1 site across 1 country: China