Reveal the Patterns of Presentation, Management and Outcome of Patients With SCLC and Stage III NSCLC in Saudi Arabia:

Lung Cancer Clinical Trial

— REVEAL  

Official title:

A Multicenter Retrospective Observational Study to Reveal the Patterns of Presentation, Management and Outcome of Patients With Small Cell Lung Cancer (SCLC) and Stage III Non-Small Cell Lung Cancer (NSCLC) in Saudi Arabia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04836975
• Other study ID #: D4191R00036
• Status: Completed
• Start date: February 28, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

• 1. 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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
Saudi Arabia	Research Site	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Healthcare resource utilization (HCRU) associated with primary SCLC (Extensive stage & Limited Stage) / stage III NSCLC	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
Other	Determining treatment effectiveness outcomes	Determining treatment effectiveness outcomes: - Disease control rate [DCR]: is a composite of ORR and stable disease	9 Months
Primary	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
Primary	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
Secondary	Patient demographic for the patients diagnosed with primary SCLC	Recording Patient demographic for the patients diagnosed with primary SCLC (Age, gender, etc..)	9 Months
Secondary	Clinical characteristics for the patients diagnosed with primary SCLC	Recording Clinical characteristics for the patients diagnosed with primary SCLC(Diagnosis, extent of the disease, etc...)	9 Months
Secondary	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
Secondary	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

External Links

•   CSR Synopsis Redacted