Clinical trial NCT05091437: DOuBLED - Doubling Outcomes by Lung Cancer Early Diagnosis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Nodules
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: INCUNA (Scientific and Technical partner)
First posted: 2021-10-25
Enrollment: 562
Sex: ALL
Minimum age (years): 35
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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).

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.

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

Primary outcomes:
measure: Time of nodule identification up to diagnosis and treatment
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Antofagasta
country: Chile
facility: Research Site
city: Concepción
country: Chile
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Cundinamarca
country: Colombia
facility: Research Site
city: San Jose
country: Costa Rica
facility: Research Site
city: Santo Domingo
country: Dominican Republic
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo Leon
city: Estado de Mexico
country: Mexico
facility: Research Site
city: Mexico City
country: Mexico
facility: Research Site
city: Panama
country: Panama
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Larisa Ramirez, MD
role: STUDY_DIRECTOR
References: