DOuBLED - Doubling Outcomes by Lung Cancer Early Diagnosis — DOuBLED  

Pulmonary Nodules Clinical Trial

Official title: Doubling Outcomes by Lung Cancer Early Diagnosis: An Observational, Study to Collect Real-world Evidence (RWE) on the Management of Pulmonary Nodules Across Latin-America

Status Active, not recruiting

Clinical Trial Summary

Early diagnosis of LC in the asymptomatic stage through intentional screening programs and/or incidental pulmonary nodule identification and follow-up are known to improve outcomes significantly. There are large gaps in the screening and early detection of LC, especially in LMIC - driven by multifactorial aspects, including a variety of socioeconomic and infrastructural factors, mainly due to limitations in the required network of specialized human resources and technical capacity. Identifying LC at an early stage allows for treatment that is more likely to be curative, thereby improving survival.

The present study aims to characterize the lung nodule journey in different hospitals/clinics across Latin America, describing the use of health resources, time to diagnosis, stage at diagnosis, and time to treatment depending on the source of nodule identification in two different cohorts (retrospective and prospective).

Clinical Trial Description

This non-interventional observational study will capture data (retrospective and prospective cohorts) from around 20 to 25 hospitals/clinics to report lung nodules (patients' journey) in Latin America.

Objectives and Hypotheses:

Primary objective

• To describe the lung nodule patient journey from the time of nodule identification through its final diagnosis, staging, and treatment decision.

Note: Lung nodules identified from different settings would be nodules identified incidentally and in lung cancer screening programs.

Secondary objective(s)

• To determine the medical specialties involved in the lung nodule study journey.

• To describe a medical specialist who first identifies the lung nodule (referral patterns).

• To estimate the proportion of benign and malignant nodules.

• To understand health care resource utilization from nodule detection to final diagnosis and management.

• Time from nodule identification until a final diagnosis and treatment decision.

• Treatment decision and specialties involved in the decision.

Study Population:

Adult ≥ 35 years of age with solid or subsolid (part solid, pure ground glass) lung nodules identified in different settings, including nodules identified incidentally and nodules identified in lung cancer screening programs could be targeted. The study population will comprise two cohorts, one prospective for subjects starting the study of pulmonary nodules since site activation and onwards, and other retrospective for subjects who started the study of pulmonary nodules from March 2019. ;

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Nodules

• NCT number: NCT05091437
• Study type: Observational
• Source: AstraZeneca
• Status: Active, not recruiting
• Start date: December 30, 2021
• Completion date: June 30, 2025