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
1 other identifier
observational
562
7 countries
12
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2021
CompletedFirst Posted
Study publicly available on registry
October 25, 2021
CompletedStudy Start
First participant enrolled
December 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedSeptember 24, 2025
September 1, 2025
2.9 years
October 12, 2021
September 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
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. \[ Fleischner Society 2017 guidelines for nodules size and definition (≥ 6 mm and \< 3 cm) for subject inclusion\].
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.
Interventions
Eligibility Criteria
Adult patients (older than 35 years) who meet inclusion and exclusion criteria will be selected from the participants hospitals/clinics
You may qualify if:
- Adult subjects (≥ 35 years of age)
- 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..
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- INCUNA (Scientific and Technical partner)collaborator
Study Sites (14)
Research Site
CABA, Argentina
Research Site
Porto Alegre, Brazil
Research Site
Rio de Janeiro, Brazil
Research Site
São Paulo, Brazil
Research Site
Antofagasta, Chile
Research Site
Concepción, Chile
Research Site
Bogotá, Colombia
Research Site
Cundinamarca, Colombia
Research Site
San José, Costa Rica
Research Site
Santo Domingo, Dominican Republic
Research Site
Monterrey, Nuevo León, Mexico
Research Site
Estado de México, Mexico
Research Site
Mexico City, Mexico
Research Site
Panama City, Panama
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Larisa Ramirez, MD
AstraZeneca
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2021
First Posted
October 25, 2021
Study Start
December 30, 2021
Primary Completion
November 30, 2024
Study Completion
November 30, 2024
Last Updated
September 24, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- 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.
- 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.
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.