DOuBLED - Doubling Outcomes by Lung Cancer Early Diagnosis

Pulmonary Nodules Clinical Trial

— DOuBLED  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05091437
• Other study ID #: D133FR00176
• Status: Active, not recruiting
• Start date: December 30, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 562
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 100 Years

Eligibility

Inclusion Criteria:

• Adult subjects (= 35 years of age)

• a) Prospective cohort: All eligible subjects with solid or subsolid (part solid, pure ground glass) lung nodule identified in imaging exams in routine clinical practice, prior to 30 days of informed consent given [please refer to: Fleischner Society 2017 guidelines for nodules size and definition (= 6 mm and < 3 cm)) for subject inclusion]. Subjects identified from different sources (Nodules identified incidentally and in lung cancer screening programs) will be considered OR b) Retrospective cohort: All eligible subjects with solid or subsolid (part solid, pure ground glass) lung nodule identified in the past; more preciously from March 2019 to the study initiation date. [Please refer to: Fleischner Society 2017 guidelines for nodules size and definition (= 6 mm and < 3 cm) for subject inclusion].

• Written informed consent to have medical data collected and stored for the prospective cohort and as guided by the local regulations for the retrospective cohort..

Exclusion Criteria:

• Subjects unable to undergo any lung diagnostic procedure.

• Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years or are deemed by the investigator to be at low risk for recurrence of that malignancy

• Subjects with calcified lung nodules with an established diagnosis

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Nodules

Intervention

Diagnostic Test:
• Observational study
Incidental lung nodules identification

Locations

Country	Name	City	State
Argentina	Research Site	Caba
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Sao Paulo
Chile	Research Site	Antofagasta
Chile	Research Site	Concepcion
Colombia	Research Site	Bogota
Colombia	Research Site	Cundinamarca
Costa Rica	Research Site	San Jose
Dominican Republic	Research Site	Santo Domingo
Mexico	Research Site	Estado de Mexico
Mexico	Research Site	Mexico City
Mexico	Research Site	Monterrey	Nuevo Leon
Panama	Research Site	Panama

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	INCUNA (Scientific and Technical partner)

Countries where clinical trial is conducted

Argentina,  Brazil,  Chile,  Colombia,  Costa Rica,  Dominican Republic,  Mexico,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of nodule identification up to diagnosis and treatment	Description of the lung nodule patient journey from the time of nodule identification through its final diagnosis, staging, and treatment decision.	24 months