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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04857333
Other study ID # KY-Q-2021-005-03
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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.
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