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A retrospective, multi-centre, observational study to describe the treatment patterns, the demographic, clinical outcomes, treatment effectiveness, and healthcare resource utilization (HCRU) for patients diagnosed with primary Small Cell Lung Cancer SCLC (Extensive stage & Limited Stage)and stage III NSCLC in a real-world setting.
A retrospective, multi-centre, observational study to describe the treatment patterns, the demographic, clinical outcomes, treatment effectiveness, and healthcare resource utilization (HCRU) for patients diagnosed with primary Small Cell Lung Cancer SCLC (Extensive stage & Limited Stage)and stage III NSCLC in a real-world setting
Cohort of patients diagnosed with primary SCLC (limited or extensive stage) or stage III NSCLC, aims to characterize the treatment patterns from the index date (defined as the date of initial diagnosis of locally advanced stage III NSCLC and SCLC) to the end of follow-up (defined as the earliest of death, last available medical record or end of the observation period "defined as the date of data abstraction") including the type of treatment received, duration of each treatment regimen, and reasons for stopping treatment regimen.
The study population will be identified by participating physicians involved in the diagnosis, treatment and management of these patients through the review of established patient medical records. Eligible patients (both alive and deceased) will have their data anonymously abstracted from their medical records into a centrally designed electronic case report form (eCRF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCLC | Patient Diagnosed with Small Cell Lung Cancer- (extensive or limited) | ||
| NSCLC | Patient diagnosed with primary stage III Non-Small cell lung Cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment patterns of patients diagnosed with primary Small Cell Lung Cancer "SCLC" | To characterize the treatment patterns of patients diagnosed with primary Small Cell Lung Cancer "SCLC" (Extensive stage & Limited Stage) through recoding type of treatment received | 9 Month |
| To characterize the treatment patterns of patients diagnosed with primary stage III Non-Small Cell Lung Cancer "NSCLC". | To characterize the treatment patterns of patients diagnosed with primary stage III Non-Small Cell Lung Cancer "NSCLC". through recoding type of treatment received | 9 Month |
| Measure | Description | Time Frame |
|---|---|---|
| Patient demographic for the patients diagnosed with primary SCLC | Recording Patient demographic for the patients diagnosed with primary SCLC (Age, gender, etc..) | 9 Months |
| Clinical characteristics for the patients diagnosed with primary SCLC |
| Measure | Description | Time Frame |
|---|---|---|
| Determining treatment effectiveness outcomes | Determining treatment effectiveness outcomes: - Objective response rate [ORR]: is defined as the proportion of patients who have a partial or complete response to therapy; it does not include stable disease | 9 Months |
| Healthcare resource utilization (HCRU) associated with primary SCLC (Extensive stage & Limited Stage) / stage III NSCLC |
Inclusion Criteria:
1. Adult male or female (≥18 years old or according to the age of majority as defined by local regulations).
2. First-ever diagnosis of lung cancer (absence of previous diagnosis of lung cancer, including SCLC and NSCLC) in the patient's medical records.
3. Patients either diagnosed with a primary diagnosis of SCLC (extensive or limited) or stage III NSCLC, confirmed by pathology, between 1st of January 2015 and 31st of December 2019.
4. Medical records available at the participating site reflect at least nine months of follow-up from the index date (unless the patient died within the first nine months of diagnosis)
Exclusion Criteria:
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patients who were diagnosed with primary Small Cell Lung Cancer (Extensive stage & Limited Stage) or stage III Non-Small Cell Lung Cancer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Riyadh | Saudi Arabia |
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| Label | URL |
|---|---|
| CSR Synopsis Redacted | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Recording Clinical characteristics for the patients diagnosed with primary SCLC(Diagnosis, extent of the disease, etc...)
| 9 Months |
| Patient demographic for patients diagnosed with primary stage III NSCLC | Recording Patient demographic for patients diagnosed with primary stage III NSCLC(Age, gender, etc..) | 9 Months |
| Clinical characteristics for the patients diagnosed with primary stage III NSCLC | Recording Clinical characteristics for the patients diagnosed with primary stage III NSCLC(Diagnosis, extent of the disease, etc...) | 9 Months |
Recording healthcare resource utilization (HCRU) associated with primary SCLC (Extensive stage & Limited Stage) / stage III NSCLC treatment. HCRU will be assessed by describing the following: Hospitalizations, Outpatient visits, Emergency department visits, Number of medical and surgical treatments received, Use of imaging studies and other procedures |
| 9 Months |
| Determining treatment effectiveness outcomes | Determining treatment effectiveness outcomes: - Disease control rate [DCR]: is a composite of ORR and stable disease | 9 Months |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |