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

GuiBin Qiao

Status: Active, not recruiting

Conditions: Pulmonary Nodule, Multiple; Pulmonary Nodule, Solitary

Treatments: Procedure: Surgical Resection; Diagnostic Test: CT scan; Drug: Antibiotics

Study type: Observational

Funder types: Other

Identifiers

NCT04857333

KY-Q-2021-005-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,800 patients

Sex: All

Ages: 14 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,800 participants in 1 patient group

Pulmonary Nodule

Description:

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.

Treatment:

Drug: Antibiotics

Procedure: Surgical Resection

Diagnostic Test: CT scan