DOuBLED - Doubling Outcomes by Lung Cancer Early Diagnosis (DOuBLED)

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

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).

Study Overview

• Status: Completed
• Conditions: Pulmonary Nodules
• Intervention / Treatment: Diagnostic test: Observational study

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 562

Contacts and Locations

Study Locations

• Argentina
  • CABA, Argentina
    • Research Site
• Brazil
  • Porto Alegre, Brazil
    • Research Site
  • Rio de Janeiro, Brazil
    • Research Site
  • São Paulo, Brazil
    • Research Site
• Chile
  • Antofagasta, Chile
    • Research Site
  • Concepción, Chile
    • Research Site
• Colombia
  • Bogotá, Colombia
    • Research Site
  • Cundinamarca, Colombia
    • Research Site
• Costa Rica
  • San José, Costa Rica
    • Research Site
• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Research Site
• Mexico
  • Estado de México, Mexico
    • Research Site
  • Mexico City, Mexico
    • Research Site
  • Nuevo León
    • Monterrey, Nuevo León, Mexico
      • Research Site
• Panama
  • Panama City, Panama
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (older than 35 years) who meet inclusion and exclusion criteria will be selected from the participants hospitals/clinics

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective; 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. [ Fleischner Society 2017 guidelines for nodules size and definition (≥ 6 mm and < 3 cm) for subject inclusion].	Diagnostic test: Observational study; Incidental lung nodules identification
Prospective; 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 [ 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.	Diagnostic test: Observational study; Incidental lung nodules identification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: INCUNA (Scientific and Technical partner)
• Investigators: Study Director: Larisa Ramirez, MD, AstraZeneca

Publications and helpful links

Helpful Links

• Redacted CSR synopsis

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2021
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: D133FR00176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.