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

Pulmonary Nodule, Solitary Clinical Trial

— DEPICT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04857333
• Other study ID #: KY-Q-2021-005-03
• Status: Active, not recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Guangdong Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1800
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Nodule, Multiple
• Pulmonary Nodule, Solitary
• Solitary Pulmonary Nodule

Intervention

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

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
GuiBin Qiao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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.
Secondary	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.