Clinical trial NCT04857333: Dynamic Evolution of Pulmonary Nodules and Influence Factors of Its Clinical Decision-making
Official title: Dynamic Evolution of Pulmonary Nodules and Influence Factors of Its Clinical Decision-making: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pulmonary Nodule, Solitary
Pulmonary Nodule, Multiple
Keywords: Pulmonary nodule
Radiologic picture
Prospective observatory study
Psychological state
Decision-making
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 1800
Sex: ALL
Minimum age (years): 14
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants in this study are diagnosed with solitory or multiple indeterminate pulmonary nodules( ≤ 3cm ), and are willing to be followed-up for continous collection of their related disease information.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to surgical resection
timeFrame: The date of first documented diagnosis of pulmonary nodule by CT scan to the date of surgical resection, up to 60 months
measure: Time to progression
timeFrame: 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 outcomes:
measure: Proportion of malignancy
timeFrame: The date of first documented diagnosis of pulmonary nodule by CT scan to the date of surgical resection, up to 60 months
measure: Change of Hospital Anxiety and Depression Scale-Anxiety (HADS-A) score
timeFrame: 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.
measure: Change of Hospital Anxiety and Depression Scale-Depression (HADS-D) score
timeFrame: 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.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References:
citation: Zhuang W, Tang Y, Xu W, Huang S, Deng C, Chen R, Zhang D, Zeng C, Tian D, Ben X, Lan Z, Wu H, Gao Z, Wang M, Chen Y, Shi Q, Qiao G. Should psychological distress be listed as a surgical indication for indeterminate pulmonary nodules: protocol for a prospective cohort study in real-world settings. J Thorac Dis. 2022 Mar;14(3):769-778. doi: 10.21037/jtd-21-1423.