Prospective Epidemiological Study of Metastatic Non Small Cell Lung Cancer (NSCLC) in Latin America
Prospective Epidemiological Study of Metastatic Non Small Cell Lung Cancer (NSCLC) in Latin America
Sponsors
Source
Latin American Cooperative Oncology Group
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Brief Summary
To describe the overall survival of advanced NSCLC in Latin America.
Detailed Description
- To describe demographic and socioeconomic characteristics of patients newly
diagnosed with advanced NSCLC
- To describe diagnostic methods, pathological profile and disease stage at diagnosis
of advanced NSCLC
- To describe the practice patterns of therapeutic agents for treatment of advanced
NSCLC
- To describe treatment responses, progression and survival times.
- To describe reasons for treatment discontinuation
- To identify associations between patient demographics, socioeconomic, pathology,
treatment sequences and overall survival;
- To define the patient experience of advanced NSCLC and identify unmet needs in their
diagnose and treatment.
Overall Status
Completed
Start Date
2018-07-25
Completion Date
2023-08-04
Primary Completion Date
2021-10-04
Study Type
Observational [Patient Registry]
Primary Outcome
Measure |
Time Frame |
|
Overall survival of advanced NSCLC in Latin America |
Annually, during 3 years |
Secondary Outcome
Measure |
Time Frame |
|
Description of socioeconomic characteristics of patients newly diagnosed with advanced NSCLC |
Annually, during 3 years |
|
Description of pathological profile of advanced NSCLC |
Annually, during 3 years |
|
Description of the practice patterns of therapeutic agents for treatment of advanced NSCLC |
Annually, during 3 years |
|
Description of the treatment responses |
Annually, during 3 years |
|
Description of Treatment discontinuation |
Annually, during 3 years |
Enrollment
700
Condition
Eligibility
Study Pop
The LATINO Lung study will prospectively recruit a minimum of 700 and up to 800 patients
with advanced NSCLC, including locally advanced disease not amenable to curative
treatment or metastatic disease from sites in Argentina, Brazil, Chile, Colombia, and
Mexico. Other countries may be invited to participate.
Patients will be recruited during an initial study period of 3 months, or more to reach
the study minimum sample size, and will be followed for 3 years.
Sampling Method
Non-Probability Sample
Criteria
Inclusion Criteria:
1. Patients aged 18 years or older;
2. Newly diagnosed Non-Small Cell Lung Cancer (NSCLC) during the period of the study
(which includes 3 months prior to site activation by LACOG, although they can have
received anti-cancer treatment during that time);
3. Histologically or cytologically confirmed advanced NSCLC:
1. Stage IIIB that progressed after curative therapy (chemoradiation and/or
surgery);
2. Stage IV metastatic disease (de novo or distant relapse)
4. Any NSCLC histological subtype and molecular mutation;
5. Any Eastern Cooperative Oncology Group (ECOG) Performance Status (0 to 4) at
diagnosis;
6. Patients assigned by treating physician to any therapy (i.e. chemotherapy, targeted
agents, immunotherapy) or palliative care;
7. Access to patient medical chart for data collection;
8. Willing and able to provide written informed consent and privacy authorization for
the release of personal health information.
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Carlos Barrios |
Principal Investigator |
Latin American Cooperative Oncology Group |
|
Gustavo Werutsky |
Principal Investigator |
Latin American Cooperative Oncology Group |
Location
Facility |
|
Centro Oncologico Riojano La Rioja 3848950 Rioja Argentina |
|
Instituto De Oncologia De Rosario Santa Fe 3836277 Rosário Argentina |
|
Centro Medico San Roque Córdoba Tucumán Province 3833578 Argentina |
|
CRIO Fortaleza 3399415 Ceará 3402362 Brazil |
|
CLION Salvador 3450554 Estado de Bahia 3471168 Brazil |
|
NOB Salvador 3450554 Estado de Bahia 3471168 Brazil |
|
Hospital Sírio- Libanês Brasília 3469058 Federal District 3463504 Brazil |
|
ICTr Curitiba 3464975 Paraná 3455077 Brazil |
|
Hospital de Câncer de Londrina Londrina 3458449 Paraná 3455077 Brazil |
|
Hospital de Caridade de Carazinho Carazinho 3466978 Rio Grande do Sul 3451133 Brazil |
|
CPO Porto Alegre 3452925 Rio Grande do Sul 3451133 Brazil |
|
HCPA Porto Alegre 3452925 Rio Grande do Sul 3451133 Brazil |
|
Hospital Moinhos de Vento Porto Alegre 3452925 Rio Grande do Sul 3451133 Brazil |
|
Hospital Mãe de Deus Porto Alegre 3452925 Rio Grande do Sul 3451133 Brazil |
|
Clínica Reichow Blumenau 3469968 Santa Catarina 3450387 Brazil |
|
CNT Itajaí Itajaí 3460845 Santa Catarina 3450387 Brazil |
|
Barretos Barretos 3470451 São Paulo 3448433 Brazil |
|
COI Américas Rio de Janeiro 3451190 Brazil |
|
INCA Rio de Janeiro 3451190 Brazil |
|
AC Camargo São Paulo 3448439 Brazil |
|
IBCC São Paulo 3448439 Brazil |
|
Fundación Arturo López Pérez Providencia 3875139 Santiago Metropolitan 3873544 Chile |
|
Clínica del Country Chapinero 7033309 Bogota D.C. 3688685 Colombia |
|
Oncomedica Montería 3674453 Departamento de Córdoba 3685889 Colombia |
|
Hospital Pablo Tobon Uribe Robledo 3670675 Medellín Colombia |
|
Centro Médico Nacional Siglo XXI Mexico City 3530597 Not Aplicable Mexico |
|
INCan Mexico City 3530597 Not Aplicable Mexico |
Location Countries
Country
Argentina
Brazil
Chile
Colombia
Mexico
Verification Date
2024-02-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keyword
Has Expanded Access
No
Condition Browse
Firstreceived Results Date
N/A
Acronym
LATINO Lung
Target Duration
3 Years
Patient Data
Sharing Ipd
Undecided
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Case-Only
Time Perspective
Prospective
Study First Submitted
January 11, 2018
Study First Submitted Qc
January 10, 2020
Study First Posted
January 13, 2020
Last Update Submitted
February 18, 2024
Last Update Submitted Qc
February 18, 2024
Last Update Posted
February 20, 2024
ClinicalTrials.gov processed this data on February 09, 2026
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.