Pulmonary NodulesDOuBLEDNCT05091437
DOuBLED - Doubling Outcomes by Lung Cancer Early Diagnosis
An observational study of Pulmonary Nodules, run by AstraZeneca at 14 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 35 to 100 years
- Conditions the study is for
- Pulmonary Nodules
- What is being tested?
- Observational study
- How many people
- 562 participants
- Where
- 14 sitesin 8 countries
- Study dates
- 30 Dec 2021to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (older than 35 years) who meet inclusion and exclusion criteria will be selected from the participants hospitals/clinics
Who may be able to join
- 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..
Who cannot join
- 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
Trial locations and contacts
14 sites in 8 countries.
14 sites in 8 countries
Brazil3 sites
Research Site
Porto Alegre
Research Site
Rio de Janeiro
Research Site
São Paulo
Mexico3 sites
Research Site
Estado de México
Research Site
Mexico City
Research Site
Monterrey, Nuevo León
About this study
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
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).
Read the 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.
- Conditions
- Pulmonary Nodules
- Being tested
- Observational study
- Medical subject headings
- Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyDiagnostic test
Incidental lung nodules identification
| Study group | Role | What they receive |
|---|---|---|
| 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]. Receives: Diagnostic Test: Observational study | |
| 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. Receives: Diagnostic Test: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start30 Dec 2021
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary NodulesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 562 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INCUNA (Scientific and Technical partner)
- Responsible party
- Sponsor
- Investigators
- Larisa Ramirez, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091437
- Sponsor's protocol ID
- D133FR00176
- Acronym
- DOuBLED
- Status last verified
- Sep 2025
- First submitted
- 12 Oct 2021
- Last updated
- 24 Sep 2025
- Results posted
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05091437
- Acronym / sponsor ID
- DOuBLED / D133FR00176
- Conditions
- Pulmonary Nodules
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 562 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- INCUNA (Scientific and Technical partner)
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | Diagnostic Test: Observational studyAll 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 | – | Diagnostic Test: Observational studyAll 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. |
Who may qualify
- Ages
- 35 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (older than 35 years) who meet inclusion and exclusion criteria will be selected from the participants hospitals/clinics
Key inclusion criteria (3 listed)
- Adult subjects (≥ 35 years of age)
Key exclusion criteria (3 listed)
- Subjects unable to undergo any lung diagnostic procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyIncidental lung nodules identification | Diagnostic test | Prospective, Retrospective |
Primary outcome
Time of nodule identification up to diagnosis and treatment
Time frame: 24 months
Description of the lung nodule patient journey from the time of nodule identification through its final diagnosis, staging, and treatment decision.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larisa Ramirez, MD study director
AstraZeneca
14 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Nodules, run by AstraZeneca at 14 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Brazil, Mexico, Chile, Colombia, Argentina and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of nodule identification up to diagnosis and treatment (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.