NCT05091437Completed
DOuBLED - Doubling Outcomes by Lung Cancer Early Diagnosis
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
Source: ClinicalTrials.gov · Last updated 24 Sept 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 562 (actual)
- First submitted
- 12 Oct 2021
- Start date
- 30 Dec 2021
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- AstraZeneca
- Diseases
- Lung cancer
- NCT number
- NCT05091437
What you commit to
- Study type: Observational
- Participants enrolled: 562
- From 30 Dec 2021 to the primary completion date, 30 Nov 2024
- 14 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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..
Age in the registry: 35 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.