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| ID | Type | Description | Link |
|---|---|---|---|
| D4191R00053 | Other Grant/Funding Number | AstraZeneca |
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The central objective of this study is to characterize the demographic of an ES-SCLC Brazilian cohort treated with durvalumab. Secondarily, to assess the outcomes of durvalumab-based regimens in 1L treatment of ES-SCLC Brazilian patients from the private health care setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients newly diagnosed with ES-SCLC | The study will include consecutive adult patients newly diagnosed with ES-SCLC (patients with the recurrent limited stage disease are also eligible). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational study | Other | This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demographic Characteristics of the Cohort | This measure encompasses relevant demographic information of the patients included in the cohort, including median age at diagnosis, gender distribution, smoking history, and World Health Organization Performance Status (WHO PS) score. These details will provide a comprehensive understanding of the patient profile within the cohort. | Baseline. |
| Clinical Characteristics of the Cohort | This measure encompasses relevant clinical information of the patients included in the cohort, including presence of hepatic and cerebral metastases, type of platinum used in first-line (1L) treatment, and diagnostic stage (III vs. IV) of CPPC-EE. These details will provide a comprehensive understanding of the patient profile within the cohort. | Baseline. |
| Comparison of Demographic and Clinical Characteristics between Recurrent and Newly Diagnosed CPPC-EE Patients | This measure focuses on comparing patients with recurrent CPPC-EE and those newly diagnosed. The incidence of disease recurrence and distinct demographic and clinical characteristics between these groups, such as age, gender, smoking history, World Health Organization Performance Status (WHO PS) score, presence of hepatic and cerebral metastases, type of platinum used in first-line (1L) treatment, and diagnostic stage, will be analyzed and reported. This will allow for a deeper understanding of differences between recurrent and newly diagnosed patients. | During the cohort follow-up, an average of 24 months, starting from diagnosis. |
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Inclusion Criteria:
Exclusion Criteria:
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Male or female patients (aged 18 years or older) with histologically- or cytologically-documented ES-SCLC receiving a durvalumab-based regimen as a first-line treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Mauro Zukin | Latin American Cooperative Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ÉTICA Clínica AMO - Assistência Multidisciplinar em Oncologia | Salvador | Estado de Bahia | 41.950-640 | Brazil | ||
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| Oncologia D'Or Unidade Esperança Pernambuco |
| Recife |
| Pernambuco |
| 50.070-480 |
| Brazil |
| Instituto D'Or de Pesquisa e Ensino RJ | Rio de Janeiro | 22.281-100 | Brazil |
| BP - A Beneficência Portuguesa de São Paulo | São Paulo | 01.323-030 | Brazil |
| A.C. Camargo Cancer Center | São Paulo | 01.509-001 | Brazil |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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