REVEAL: Reveal the Patterns of Presentation, Management and Outcome of Patients With SCLC and Stage III NSCLC in Saudi Arabia:
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| SCLC Patient Diagnosed with Small Cell Lung Cancer- (extensive or limited) |
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| NSCLC Patient diagnosed with primary stage III Non-Small cell lung Cancer |
Outcome Measures
Primary Outcome Measures
- Treatment patterns of patients diagnosed with primary Small Cell Lung Cancer "SCLC" [9 Month]
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
- To characterize the treatment patterns of patients diagnosed with primary stage III Non-Small Cell Lung Cancer "NSCLC". [9 Month]
To characterize the treatment patterns of patients diagnosed with primary stage III Non-Small Cell Lung Cancer "NSCLC". through recoding type of treatment received
Secondary Outcome Measures
- Patient demographic for the patients diagnosed with primary SCLC [9 Months]
Recording Patient demographic for the patients diagnosed with primary SCLC (Age, gender, etc..)
- Clinical characteristics for the patients diagnosed with primary SCLC [9 Months]
Recording Clinical characteristics for the patients diagnosed with primary SCLC(Diagnosis, extent of the disease, etc...)
- Patient demographic for patients diagnosed with primary stage III NSCLC [9 Months]
Recording Patient demographic for patients diagnosed with primary stage III NSCLC(Age, gender, etc..)
- Clinical characteristics for the patients diagnosed with primary stage III NSCLC [9 Months]
Recording Clinical characteristics for the patients diagnosed with primary stage III NSCLC(Diagnosis, extent of the disease, etc...)
Other Outcome Measures
- Determining treatment effectiveness outcomes [9 Months]
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
- Healthcare resource utilization (HCRU) associated with primary SCLC (Extensive stage & Limited Stage) / stage III NSCLC [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
- Determining treatment effectiveness outcomes [9 Months]
Determining treatment effectiveness outcomes: - Disease control rate [DCR]: is a composite of ORR and stable disease
Eligibility Criteria
Criteria
Inclusion Criteria:
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- Adult male or female (≥18 years old or according to the age of majority as defined by local regulations).
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First-ever diagnosis of lung cancer (absence of previous diagnosis of lung cancer, including SCLC and NSCLC) in the patient's medical records.
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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.
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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 with concomitant cancer at the time of diagnosis other than SCLC or stage III NSCLC, except for non-metastatic non-melanoma skin cancers, or in situ or benign neoplasms. Cancer will be considered concomitant if it occurs within five years of NSCLC or SCLC diagnosis 2. Patients initially diagnosed with stage I to II NSCLC who have progressed to stage III 3. Current or prior use of "Durvalumab" treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Dammam | Saudi Arabia | ||
| 2 | Research Site | Riyadh | Saudi Arabia | ||
| 3 | Research Site | Riyadh | Saudi Arabia |
Sponsors and Collaborators
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D4191R00036