Lung CancerREVEALNCT04836975
Reveal the Patterns of Presentation, Management and Outcome of Patients With SCLC and Stage III NSCLC in Saudi Arabia:
An observational study of Lung Cancer, run by AstraZeneca at 1 site in Saudi Arabia.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- How many people
- 45 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 28 Feb 2022to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who were diagnosed with primary Small Cell Lung Cancer (Extensive stage \& Limited Stage) or stage III Non-Small Cell Lung Cancer
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Lung Cancer
- Keywords
- Small Cell Lung Cancer (SCLC), Stage III Non-Small Cell Lung Cancer (NSCLC)
- Medical subject headings
- Lung Neoplasms, Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SCLC | Patient Diagnosed with Small Cell Lung Cancer- (extensive or limited) | |
| NSCLC | Patient diagnosed with primary stage III Non-Small cell lung Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 9 Month
Secondary outcomes (4)
Patient demographic for the patients diagnosed with primary SCLC
Recording Patient demographic for the patients diagnosed with primary SCLC (Age, gender, etc..)
Measured: 9 Months
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...)
Measured: 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..)
Measured: 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...)
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start28 Feb 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836975
- Sponsor's protocol ID
- D4191R00036
- Acronym
- REVEAL
- Status last verified
- Jan 2024
- First submitted
- 6 Apr 2021
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04836975
- Acronym / sponsor ID
- REVEAL / D4191R00036
- Conditions
- Lung Cancer
- Keywords
- Small Cell Lung Cancer (SCLC), Stage III Non-Small Cell Lung Cancer (NSCLC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCLC | – | –Patient Diagnosed with Small Cell Lung Cancer- (extensive or limited) |
| NSCLC | – | –Patient diagnosed with primary stage III Non-Small cell lung Cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who were diagnosed with primary Small Cell Lung Cancer (Extensive stage \& Limited Stage) or stage III Non-Small Cell Lung Cancer
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
4 secondary outcomes
Patient demographic for the patients diagnosed with primary SCLC
Time frame: 9 Months
Clinical characteristics for the patients diagnosed with primary SCLC
Time frame: 9 Months
Patient demographic for patients diagnosed with primary stage III NSCLC
Time frame: 9 Months
Clinical characteristics for the patients diagnosed with primary stage III NSCLC
Time frame: 9 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- CSR Synopsis RedactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by AstraZeneca at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment patterns of patients diagnosed with primary Small Cell Lung Cancer "SCLC" (time frame: 9 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.