Clinical trial

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

Name

KY-Q-2021-005-03

Description

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.

Trial arms

Trial start

2021-01-01

Estimated PCD

2023-12-31

Trial end

2025-12-31

Status

Active (not recruiting)

Treatment

CT scan

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

Arms:

Pulmonary Nodule

Antibiotics

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

Arms:

Pulmonary Nodule

Surgical Resection

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

Arms:

Pulmonary Nodule

Size

1800

Primary endpoint

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 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

Eligibility criteria

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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '3 Years', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1800, 'type': 'ACTUAL'}}

Updated at

2023-03-16

1 organization

1 product

3 indications

Organization

Product

Indication

Indication

Indication