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OpenTrials
Completed

NCT Number: NCT04836975

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. 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)

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

Treatment and study plan

Primary outcomes

  1. Treatment patterns of patients diagnosed with primary Small Cell Lung Cancer "SCLC"

    Time frame: 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

  2. To characterize the treatment patterns of patients diagnosed with primary stage III Non-Small Cell Lung Cancer "NSCLC".

    Time frame: 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 outcomes

  1. Patient demographic for the patients diagnosed with primary SCLC

    Time frame: 9 Months

    Recording Patient demographic for the patients diagnosed with primary SCLC (Age, gender, etc..)

  2. Clinical characteristics for the patients diagnosed with primary SCLC

    Time frame: 9 Months

    Recording Clinical characteristics for the patients diagnosed with primary SCLC(Diagnosis, extent of the disease, etc...)

  3. Patient demographic for patients diagnosed with primary stage III NSCLC

    Time frame: 9 Months

    Recording Patient demographic for patients diagnosed with primary stage III NSCLC(Age, gender, etc..)

  4. Clinical characteristics for the patients diagnosed with primary stage III NSCLC

    Time frame: 9 Months

    Recording Clinical characteristics for the patients diagnosed with primary stage III NSCLC(Diagnosis, extent of the disease, etc...)

Other outcomes

  1. Determining treatment effectiveness outcomes

    Time frame: 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
  2. Healthcare resource utilization (HCRU) associated with primary SCLC (Extensive stage & Limited Stage) / stage III NSCLC

    Time frame: 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

  3. Determining treatment effectiveness outcomes

    Time frame: 9 Months

    Determining treatment effectiveness outcomes:

    • Disease control rate [DCR]: is a composite of ORR and stable disease

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: REVEAL

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2021
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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