DEPICT: Dynamic Evolution of Pulmonary Nodules and Influence Factors of Its Clinical Decision-making
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
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
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Outcome Measures
Primary Outcome Measures
- Time to 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 calculated from the date of identification of pulmonary nodule to the date of surgical resection
- Time to progression [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]
Time calculated from the date of identification of pulmonary nodule to the date of progression of pulmonary nodule based on evaluation of CT imaging
Secondary Outcome Measures
- 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]
Proportion of malignant findings by pathological examination in all patients receiving surgical resection
- 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.]
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).
- 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.]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with pulmonary nodules ≤ 3cm
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Patients who provide electronic, written or oral consent to be enrolled in the follow-up cohort
Exclusion Criteria:
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Patients with a surgical history of pulmonary nodules;
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Patients who have obtained pathological diagnosis through surgery or non-surgical methods such as puncture;
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Patients with pulmonary nodules that are likely metastatic from other sites;
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Refuse to participate in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China | 510080 |
Sponsors and Collaborators
- GuiBin Qiao
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KY-Q-2021-005-03