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

NCT04836975 | Completed

• 1 other identifier: D4191R00036
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Small Cell Lung Cancer (SCLC); Stage III Non-Small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Patient demographic for the patients diagnosed with primary SCLC

  9 Months

• Clinical characteristics for the patients diagnosed with primary SCLC

  9 Months

• Patient demographic for patients diagnosed with primary stage III NSCLC

  9 Months

• Clinical characteristics for the patients diagnosed with primary stage III NSCLC

  9 Months

Other Outcomes (3)

• Determining treatment effectiveness outcomes

  9 Months

• Healthcare resource utilization (HCRU) associated with primary SCLC (Extensive stage & Limited Stage) / stage III NSCLC

  9 Months

• Determining treatment effectiveness outcomes

  9 Months

Study Arms (2)

SCLC

Patient Diagnosed with Small Cell Lung Cancer- (extensive or limited)

NSCLC

Patient diagnosed with primary stage III Non-Small cell lung Cancer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who were diagnosed with primary Small Cell Lung Cancer (Extensive stage \& Limited Stage) or stage III Non-Small Cell Lung Cancer

You may qualify if:

• \. Adult male or female (≥18 years old or according to the age of majority as defined by local regulations).
• \. First-ever diagnosis of lung cancer (absence of previous diagnosis of lung cancer, including SCLC and NSCLC) in the patient's medical records.
• \. 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.
• \. 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)

You may not qualify if:

• \. 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Riyadh, Saudi Arabia

Location

Related Links

• CSR Synopsis Redacted

MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: February 28, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: 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.
• Access Criteria: 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.

Locations

SA (1)