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

NCT05091437

CompletedN/A

Sponsor: AstraZeneca

Conditions: Pulmonary Nodules

Interventions: Observational study

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

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).

Eligibility overview

Sex: ALL

Age: 35 Years to 100 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (14)
  • CABA, Argentina
  • Porto Alegre, Brazil
  • Rio de Janeiro, Brazil
  • São Paulo, Brazil
  • Antofagasta, Chile
  • Concepción, Chile
  • Bogotá, Colombia
  • Cundinamarca, Colombia
  • San José, Costa Rica
  • Santo Domingo, Dominican Republic
  • Monterrey, Nuevo León, Mexico
  • Estado de México, Mexico
  • Mexico City, Mexico
  • Panama City, Panama