Lung Nodule Prospective Database

NCT03922828 | Completed DMC

• 1 other identifier: 2018/2596
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer is one of the most common cancers in the Singapore population, being the 2nd most commonly diagnosed cancer amongst males and 3rd most commonly diagnosed cancer amongst females. Pulmonologists, oncologists and thoracic surgeons are often consulted for the evaluation of imaging-identified pulmonary nodules. These may have been identified either incidentally or through screening. The majority of these are indeterminate and definitive investigation with biopsy or resection is invasive and not without risk. Hence, current consensus guidelines adopt a largely expectant strategy in the management of these indeterminate pulmonary nodules. There is substantial evidence that lung cancer in Asians may be unique with multiple driver mutations, lower age of presentation and may be independent of tobacco exposure. In addition, there are guidelines that recommend that the management of lung nodules in Asia should account for these differences. However, the evidence for alternative recommendations is lacking. The aim of the study will be to identify radiological and clinical predictors that can improve the diagnosis of lung nodules. These predictors may help build a model for lung nodule evaluation and surveillance. Prospective database of subjects meeting all of the following inclusion criteria to participate in this study.

1. 1.Evidence of lung nodule on chest radiograph or Computed Tomography regardless of underlying aetiology
2. 2.Age ³ 21 years old
3. 3.Ability to provide informed consent This study will collect existing or prospective data that is part of standard clinical care from the electronic medical record of patients (ambulatory and inpatient from May 2018-2023.

Conditions

Lung Neoplasms; Lung Cancer; Lung Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Histology

  Malignant or benign

  3 years

Interventions

CT scans DIAGNOSTIC_TEST

CT surveillance, Lung biopsy, Lung resection

Eligibility Criteria

• Age: 21 Years - 120 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lung nodules

You may qualify if:

• Evidence of lung nodule on chest radiograph or Computed Tomography regardless of underlying aetiology
• Age \> 21 years old
• Ability to provide informed consent

You may not qualify if:

• Subjects who no radiographic evidence of lung nodules or who are unwilling/unable to provide informed consent

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singhealth Institutions

Singapore, 169856, Singapore

Location

MeSH Terms

Conditions

Lung Neoplasms; Adenocarcinoma of Lung

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 22, 2019
• Study Start: May 1, 2018
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)