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

NCT04857333 | Unknown DMC

• 1 other identifier: KY-Q-2021-005-03
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Nodule, Solitary; Pulmonary Nodule, Multiple

Keywords

Pulmonary nodule; Radiologic picture; Prospective observatory study; Psychological state; Decision-making

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

• 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.

• 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.

Study Arms (1)

Pulmonary Nodule

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; Drug: Antibiotics; Procedure: Surgical Resection

Interventions

CT scan DIAGNOSTIC_TEST

For patients with low-risk pulmonary nodules, follow-up CT scan is recommended

Pulmonary Nodule

Antibiotics DRUG

For pulmonary nodules with features of infectious disease, antibiotics is recommended

Pulmonary Nodule

Surgical Resection PROCEDURE

For persistent high-risk pulmonary nodules, surgical resection is recommended

Pulmonary Nodule

Eligibility Criteria

• Age: 14 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with pulmonary nodules ≤ 3cm
• Patients who provide electronic, written or oral consent to be enrolled in the follow-up cohort

You may not qualify if:

• 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.

Sponsors & Collaborators

• GuiBin Qiao: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

Related Publications (2)

• Wu J, Zhuang W, Chen R, Xu H, Li Z, Lan Z, Xia X, He Z, Li S, Deng C, Xu W, Shi Q, Tang Y, Qiao G. Impact of surgery versus follow-up on psychological distress in patients with indeterminate pulmonary nodules: A prospective observational study. Qual Life Res. 2025 Apr;34(4):1167-1177. doi: 10.1007/s11136-024-03876-w. Epub 2025 Jan 15.

  PMID: 39812961 DERIVED

• 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.

  PMID: 35399240 DERIVED

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Interventions

Tomography, X-Ray Computed; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Administrative Director, Department of Thoracic Surgery

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 23, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)