Lung MalignancyCREATENCT05817110
Validating Artificial Intelligence Effectiveness Defined Lung Nodule Malignancy Score in Patients With Pulmonary Nodule.
An observational study of Lung Malignancy, run by AstraZeneca at 22 sites in 5 countries.
Trial summary
Artificial intelligence (AI) based algorithms have demonstrated increased accuracy in predicting the risk of Lung Cancer among patients with an incidental pulmonary nodule (IPN) on chest radiographs. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Lung Malignancy
- What is being tested?
- Participant Cohort
- How many people
- 712 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 20 Apr 2023to 6 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults patient (35years or more) coming for chest X-ray at the institution.
Who may be able to join
- Male or female patients aged >35 years
- Patients diagnosed with incidental pulmonary nodule (IPN) on CXR (chest x-ray) by qXR and confirmed by the radiologist at the site with nodule size ≥8 and ≤30 mm.
Who cannot join
- Any medical or other contraindications for a CT scan
- Nondigital (chest x-ray)CXR
- CT scan is done more than 6 months after (chest x-ray) CXR
- Patients with already diagnosed lung cancer
- The patients referred for an X-Ray for a suspicious Lung cancer
- A patient who already participated in the study.
Trial locations and contacts
22 sites in 5 countries.
22 sites in 5 countries
India15 sites
Research Site
Bangalore, 560011
Research Site
Bangalore, 560038
Research Site
Chennai, 600026
Research Site
Chennai, 600040
Research Site
Chennai, 600045
Research Site
Chennai, 600053
Research Site
Chennai, 600116
Research Site
Gurugram, Haryana, 122001
Research Site
Hyderabad, Telangana, 500003
Research Site
Kolkata, 700025
Research Site
Mumbai, 400069
Research Site
New Delhi, National Capital Territory of Delhi, 110005
Research Site
New Delhi, National Capital Territory of Delhi, 110017
Research Site
New Delhi, National Capital Territory of Delhi, 201012
Research Site
Pune, 411011
Mexico2 sites
Research Site
Mexico City, 6720
Research Site
Monterrey, Nuevo León, 64460
Turkey (Türkiye)2 sites
Research Site
Ankara, Turkey, 06100
Research Site
Mersin, Turkey, 33010
About this study
Official title: Prospective Realworld Cohort Study to Validate Effectiveness of an Artificial Intelligence Defined Lung Nodule Malignancy Score in Patients With Pulmonary Nodule Multicentric, Multinational, Prospective, Observational Study.
Artificial intelligence (AI) based algorithms have demonstrated increased accuracy in predicting the risk of Lung Cancer among patients with an incidental pulmonary nodule (IPN) on chest radiographs. Qure.ai, an AI company specializing in the reading of chest X- Rays (CXRs) by a proprietary algorithm and has developed a new model, qXR, that can report the lung nodule malignancy score (LNMS) based on lung nodule features.
Our study aims to prospectively validate the lung nodule malignancy score against radiologist assessment of CT scans and Lung CT Screening Reporting and Data System score (Lung-RADS).(lung RADS score explained below) Thus, lung nodule malignancy score (interpreted by qXR as a high or low category) will be compared with radiologist-based assessment probability of CT scan and Lung-RADS assessment. The results of this prospective observational study will pave the way for improved nodule management, leading to better clinical outcomes in patients with incidental pulmonary nodule (IPNs), especially concerning malignancy assessment.
Read the detailed description
A multicentric, multinational, prospective, observational study to validate qXR-Lung nodule malignancy score as a binary categorization of the risk of Lung cancer as high or low among patients with an incidental pulmonary nodule (IPN) on chest radiographs. The study will be implemented across selected countries in the AstraZeneca International Region (e.g., Philippines, Malaysia, Saudi Arabia, United Arab Emirates, Kuwait, Thailand, Taiwan, Hong Kong, India, Brazil, Argentina, Colombia).
Patients coming to the facility for x-rays for any reason will undergo x-rays as ordered by their treating clinician. Adult patients diagnosed with incidental pulmonary nodule( IPN) on Chest X-ray (CXR) with nodule size ≥8 and ≤30 mm, will be invited to participate in the study and enrolled after obtaining their written informed consent. In case of any nodule detection by qXR, it will be classified either as low-risk Lung nodule malignancy score (LNMS) or high-risk LNMS. The X-ray reporting physician will decide the qXR report for the presence of a nodule.
CT scan will be performed after obtaining consent for the low-dose CT scan from patients.The clinical site's radiologist and an independent radiologist not associated with the clinical site will report the CT scan and the qXR-LNMS category. Radiologists' interpretation will be based on examining a nodule on a CT scan film (naked eye examination). Radiologists will first rate their CT scan interpretation of the nodule on the Likert scale as: non-malignant: 1; probable non-malignant: 2; uncertain: 3; probable malignant: 4; malignant: 5. In addition, the radiologists will assign a Lung-RADS and then give an overall assessment of the risk of malignancy as high or low.
. This study is minimal to no risk to the patient. The study duration for a participant will be approximately 30 months from the enrolment. The study will have 2 phases. Phase 1 will be from enrolment until CT data collection. The CT data collection day will end Phase 1 (End of Phase-1). Phase 2 will be from CT data collection until 24 months from CT which is the end of Phase 2. The study visits in this period will be per clinical follow-up and will not be mandatory.
- Conditions
- Lung Malignancy
- Being tested
- Participant Cohort
- Keywords
- Artificial Intelligence, Lung malignancy nodule score, Pulmonary Nodule, qXR-LNMS, Lung Cancer, Lung RADS, CT scan
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participant CohortOther
Patients coming to the facility for chest x-rays for any reason, will undergo x-rays as ordered by their treating clinician. In case of any nodule detection by qXR, it will be classified either as low-risk (Lung nodule malignancy score ) LNMS or high-risk LNMS confirmed by radiologist. Then if patient is eligible will be included in the study and a CT Scan will be requested upon enrolment of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Computed tomography Cohort | In case of any nodule detection by qXR, it will be classified either as low-risk LNMS(lung nodule malignancy score ) or high-risk LNMS confirmed by radiologist. The patient will be requested to get a CT scan after enrolment in the study. Receives: Other: Participant Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the positive and negative predictive values of qXR LNMS (lung nodule malignancy score ) in a multi-centre real-world setting.
PPV( positive predictive value) of qXR-LNMS using a panel of radiologists assigning high-risk based on CT (done within 180 days from Xray) as the reference standard The PPV here is the number of nodules rated as high risk as assessed by a reference standard (a panel of radiologists) on CT divided by the total number of high-risk nodules as reported by qXR-LNMS (lung nodule malignancy score ) (n = 500) NPV( negative predictive value) of qXR-LNMS using panel of radiologists assigning low-risk based on CT (done within 180days from X-ray) as reference standard.
The NPV here is number of nodules rated as low risk as assessed by a reference standard (a panel of radiologists) on CT divided by total number of low-risk nodules as reported by qXR-LNMS (lung nodule malignancy score ) (n = 200)
Measured: 6 months from the Last subject In.
Secondary outcomes (1)
Demographic and clinical factors associated with high or low predictive values association of qXR LNMS with the Mayo score model.
PPV (positive predictive value) of qXR-LNMS (lung nodule malignancy score) using panel of radiologists assigning Lung-RADS (lung RADS score explained in description )>4A based on CT as reference standard.
The PPV here is number of nodules rated as Lung-RADS>4A as assessed by a reference standard (a panel of radiologists) on CT divided by total number of high-risk nodules as reported by qXR-LNMS (n = 500) NPV ( negative predictive value) of qXR-LNMS using a panel of radiologists assigning Lung-RADS<4A based on CT as the reference standard The NPV here is the number of nodules rated as Lung-RADS<4A as assessed by a reference standard (a panel of radiologists) on CT divided by the total number of low-risk nodules as reported by qXR-LNMS (n = 200)
Measured: 2 and half years from Last subject In.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start20 Apr 2023
- Primary completion6 Dec 2026 (estimated)
- Study completion6 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung MalignancyStudies 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
- Prospective
- Enrolment
- 712 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817110
- Sponsor's protocol ID
- D133FR00178
- Acronym
- CREATE
- Status last verified
- Aug 2026
- First submitted
- 14 Mar 2023
- Last updated
- 20 Aug 2026
- 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.
Publications
Koksal D, Govindarajan A, Gonuguntla HK, Nayci S, Cordova R, Zidan MH, McCutcheon S, Saha A, Kantharaju P, Sen S, Agrawal R, Wulandari L. Evaluation of an Artificial Intelligence Defined Lung Nodule Malignancy Score in Incidental Pulmonary Nodules: The CREATE Study. Mayo Clin Proc Digit Health. 2026 Jan 19;4(1):100335. doi: 10.1016/j.mcpdig.2026.100335. eCollection 2026 Mar.
PubMed 41716936
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Realworld Cohort Study to Validate Effectiveness of an Artificial Intelligence Defined Lung Nodule Malignancy Score in Patients With Pulmonary Nodule Multicentric, Multinational, Prospective, Observational Study.
- ClinicalTrials.gov ID
- NCT05817110
- Acronym / sponsor ID
- CREATE / D133FR00178
- Conditions
- Lung Malignancy
- Keywords
- Artificial Intelligence, Lung malignancy nodule score, Pulmonary Nodule, qXR-LNMS, Lung Cancer, Lung RADS, CT scan
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 712 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 6 Dec 2026 (estimated)
- Study completion
- 6 Dec 2026 (estimated)
- First posted
- 18 Apr 2023 (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.
Artificial intelligence (AI) based algorithms have demonstrated increased accuracy in predicting the risk of Lung Cancer among patients with an incidental pulmonary nodule (IPN) on chest radiographs. Qure.ai, an AI company specializing in the reading of chest X- Rays (CXRs) by a proprietary algorithm and has developed a new model, qXR, that can report the lung nodule malignancy score (LNMS) based on lung nodule features.
Our study aims to prospectively validate the lung nodule malignancy score against radiologist assessment of CT scans and Lung CT Screening Reporting and Data System score (Lung-RADS).(lung RADS score explained below) Thus, lung nodule malignancy score (interpreted by qXR as a high or low category) will be compared with radiologist-based assessment probability of CT scan and Lung-RADS assessment. The results of this prospective observational study will pave the way for improved nodule management, leading to better clinical outcomes in patients with incidental pulmonary nodule (IPNs), especially concerning malignancy assessment.
Detailed description
A multicentric, multinational, prospective, observational study to validate qXR-Lung nodule malignancy score as a binary categorization of the risk of Lung cancer as high or low among patients with an incidental pulmonary nodule (IPN) on chest radiographs. The study will be implemented across selected countries in the AstraZeneca International Region (e.g., Philippines, Malaysia, Saudi Arabia, United Arab Emirates, Kuwait, Thailand, Taiwan, Hong Kong, India, Brazil, Argentina, Colombia).
Patients coming to the facility for x-rays for any reason will undergo x-rays as ordered by their treating clinician. Adult patients diagnosed with incidental pulmonary nodule( IPN) on Chest X-ray (CXR) with nodule size ≥8 and ≤30 mm, will be invited to participate in the study and enrolled after obtaining their written informed consent. In case of any nodule detection by qXR, it will be classified either as low-risk Lung nodule malignancy score (LNMS) or high-risk LNMS. The X-ray reporting physician will decide the qXR report for the presence of a nodule.
CT scan will be performed after obtaining consent for the low-dose CT scan from patients.The clinical site's radiologist and an independent radiologist not associated with the clinical site will report the CT scan and the qXR-LNMS category. Radiologists' interpretation will be based on examining a nodule on a CT scan film (naked eye examination). Radiologists will first rate their CT scan interpretation of the nodule on the Likert scale as: non-malignant: 1; probable non-malignant: 2; uncertain: 3; probable malignant: 4; malignant: 5. In addition, the radiologists will assign a Lung-RADS and then give an overall assessment of the risk of malignancy as high or low.
. This study is minimal to no risk to the patient. The study duration for a participant will be approximately 30 months from the enrolment. The study will have 2 phases. Phase 1 will be from enrolment until CT data collection. The CT data collection day will end Phase 1 (End of Phase-1). Phase 2 will be from CT data collection until 24 months from CT which is the end of Phase 2. The study visits in this period will be per clinical follow-up and will not be mandatory.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computed tomography Cohort | – | Other: Participant CohortIn case of any nodule detection by qXR, it will be classified either as low-risk LNMS(lung nodule malignancy score ) or high-risk LNMS confirmed by radiologist. The patient will be requested to get a CT scan after enrolment in the study. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patient (35years or more) coming for chest X-ray at the institution.
Key inclusion criteria (2 listed)
- Male or female patients aged >35 years
- Patients diagnosed with incidental pulmonary nodule (IPN) on CXR (chest x-ray) by qXR and confirmed by the radiologist at the site with nodule size ≥8 and ≤30 mm.
Key exclusion criteria (6 listed)
- Any medical or other contraindications for a CT scan
- Nondigital (chest x-ray)CXR
- CT scan is done more than 6 months after (chest x-ray) CXR
- Patients with already diagnosed lung cancer
- The patients referred for an X-Ray for a suspicious Lung cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participant CohortPatients coming to the facility for chest x-rays for any reason, will undergo x-rays as ordered by their treating clinician. In case of any nodule detection by qXR, it will be classified either as low-risk (Lung nodule malignancy score ) LNMS or high-risk LNMS confirmed by radiologist. Then if patient is eligible will be included in the study and a CT Scan will be requested upon enrolment of the patient. | Other | Computed tomography Cohort |
Primary outcome
To estimate the positive and negative predictive values of qXR LNMS (lung nodule malignancy score ) in a multi-centre real-world setting.
Time frame: 6 months from the Last subject In.
PPV( positive predictive value) of qXR-LNMS using a panel of radiologists assigning high-risk based on CT (done within 180 days from Xray) as the reference standard The PPV here is the number of nodules rated as high risk as assessed by a reference standard (a panel of radiologists) on CT divided by the total number of high-risk nodules as reported by qXR-LNMS (lung nodule malignancy score ) (n = 500) NPV( negative predictive value) of qXR-LNMS using panel of radiologists assigning low-risk based on CT (done within 180days from X-ray) as reference standard. The NPV here is number of nodules rated as low risk as assessed by a reference standard (a panel of radiologists) on CT divided by total number of low-risk nodules as reported by qXR-LNMS (lung nodule malignancy score ) (n = 200)
1 secondary outcome
Demographic and clinical factors associated with high or low predictive values association of qXR LNMS with the Mayo score model.
Time frame: 2 and half years from Last subject In.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Derived from this study: PubMed 41716936Koksal D, Govindarajan A, Gonuguntla HK, Nayci S, Cordova R, Zidan MH, McCutcheon S, Saha A, Kantharaju P, Sen S, Agrawal R, Wulandari L. Evaluation of an Artificial Intelligence Defined Lung Nodule Malignancy Score in Incidental Pulmonary Nodules: The CREATE Study. Mayo Clin Proc Digit Health. 2026 Jan 19;4(1):100335. doi: 10.1016/j.mcpdig.2026.100335. eCollection 2026 Mar.
- 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.
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Malignancy, run by AstraZeneca at 22 sites in 5 countries.
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 2 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in India, Egypt, Mexico, Turkey (Türkiye), Indonesia. 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?
This study is still under way. Results are not available in the source record yet.
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?
To estimate the positive and negative predictive values of qXR LNMS (lung nodule malignancy score ) in a multi-centre real-world setting. (time frame: 6 months from the Last subject In.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05817110, which also lists 1 linked publication.
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 20 Aug 2026.