Lung Cancer ScreeningCLEARNCT07216144
Centralized Lung Cancer Screening Engagement in At-Risk Populations
A study testing Centralized patient outreach for lung cancer screening in people with Lung Cancer Screening, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This study will assess the impact of centralized outreach on lung cancer screening completion among individuals served by Federally Qualified Health Centers. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Lung Cancer Screening
- What is being tested?
- Centralized patient outreach for lung cancer screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2025to Aug 2027
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 50 to 80 years
- Current or past smokers
- Individuals without a recorded LDCT scan within the past year
- Individuals without a prior lung cancer diagnosis
- Active patients of Ryan Health
- Individuals with a mailing address in the New York City area and a phone number on file
Who cannot join
- Individuals aged less than 50 or above 80 years
- Individuals without smoking history
- Individuals with a recorded LDCT scan within the past year
- Individuals with a prior lung cancer diagnosis
- Individuals without a mailing address in the New York City area or a phone number on file
- Individuals served by one of Ryan Health clinics where the centralized patient outreach was developed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Centralized Lung Cancer Screening Engagement in At-Risk Populations (CLEAR)
This study will assess the impact of centralized outreach on lung cancer screening completion among individuals served by Federally Qualified Health Centers.
Read the detailed description
This will be a two-arm, parallel, pragmatic randomized controlled trial (RCT) to evaluate the effectiveness of a centralized patient outreach strategy in increasing lung cancer screening (LCS) completion among populations served by Federally Qualified Health Centers (FQHCs). This study will randomize individuals potentially eligible for LCS (50-80 years, current or past smokers) to receive centralized patient outreach in addition to usual care (outreach arm) and usual care alone (usual care arm). Individuals assigned to the outreach arm will receive centralized patient outreach from the Lung screening team through a letter followed by up to three attempts of telephone contact. Individuals assigned to the usual care arm will not receive any contact during the study period and the referral for LCS will be made at the treating physician's discretion.
- Conditions
- Lung Cancer Screening
- Being tested
- Centralized patient outreach for lung cancer screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centralized patient outreach for lung cancer screeningBehavioural
Centralized patient outreach for lung cancer screening will be conducted by the lung screening team and will consist of a letter followed by telephone contact. One week following the mail invitation, a senior patient coordinator (SPC) will make telephone contact with individuals to pre-screen eligibility determination based on pack-year smoking history. Up to three telephone contact attempts will be made within two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Outreach arm | Experimental | Individuals in the outreach arm will receive centralized patient outreach for lung cancer screening in addition to usual care. Receives: Behavioral: Centralized patient outreach for lung cancer screening |
| Usual care arm | No intervention | Individuals in the usual care arm will receive usual care and will not receive any outreach contacts (mail or telephone) within 15 months after randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of individuals completing low-dose CT (LDCT) within 15 months of randomization.
Measured: Within 15 months of randomization
Secondary outcomes (4)
LDCT scan findings: Lung Imaging Reporting and Data System (Lung-RADS)
Proportion of individuals with Lung-RADS 1, 2, 3, and 4
Measured: Within 15 months of randomization
LDCT incident findings
Proportion of individuals with incident findings on LDCT (including moderate to severe coronary artery calcification, lung-mediastinal findings, moderate to severe emphysema, and abdominal findings)
Measured: Within 15 months of randomization
Follow-up care
Proportion of individuals receiving a biopsy or lung cancer treatment
Measured: Within 6 months after screening
Average costs of implementing centralized outreach per individual
Measured: Within 15 months of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start15 Oct 2025
- Primary completionFeb 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jialin Mao, MD, PhD, Principal investigator, Weill Medical College of Cornell UniversityBradley B Pua, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216144
- Sponsor's protocol ID
- 25-04028716
- Acronym
- CLEAR
- Status last verified
- Dec 2025
- First submitted
- 8 Oct 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data collected during the trial.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Centralized Lung Cancer Screening Engagement in At-Risk Populations (CLEAR)
- ClinicalTrials.gov ID
- NCT07216144
- Acronym / sponsor ID
- CLEAR / 25-04028716
- Conditions
- Lung Cancer Screening
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 14 Oct 2025 (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.
This study will assess the impact of centralized outreach on lung cancer screening completion among individuals served by Federally Qualified Health Centers.
Detailed description
This will be a two-arm, parallel, pragmatic randomized controlled trial (RCT) to evaluate the effectiveness of a centralized patient outreach strategy in increasing lung cancer screening (LCS) completion among populations served by Federally Qualified Health Centers (FQHCs). This study will randomize individuals potentially eligible for LCS (50-80 years, current or past smokers) to receive centralized patient outreach in addition to usual care (outreach arm) and usual care alone (usual care arm). Individuals assigned to the outreach arm will receive centralized patient outreach from the Lung screening team through a letter followed by up to three attempts of telephone contact. Individuals assigned to the usual care arm will not receive any contact during the study period and the referral for LCS will be made at the treating physician's discretion.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outreach arm | Experimental | Behavioral: Centralized patient outreach for lung cancer screeningIndividuals in the outreach arm will receive centralized patient outreach for lung cancer screening in addition to usual care. |
| Usual care arm | No intervention | –Individuals in the usual care arm will receive usual care and will not receive any outreach contacts (mail or telephone) within 15 months after randomization. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 50 to 80 years
- Current or past smokers
- Individuals without a recorded LDCT scan within the past year
- Individuals without a prior lung cancer diagnosis
- Active patients of Ryan Health
Key exclusion criteria (6 listed)
- Individuals aged less than 50 or above 80 years
- Individuals without smoking history
- Individuals with a recorded LDCT scan within the past year
- Individuals with a prior lung cancer diagnosis
- Individuals without a mailing address in the New York City area or a phone number on file
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 |
|---|---|---|
| Centralized patient outreach for lung cancer screeningCentralized patient outreach for lung cancer screening will be conducted by the lung screening team and will consist of a letter followed by telephone contact. One week following the mail invitation, a senior patient coordinator (SPC) will make telephone contact with individuals to pre-screen eligibility determination based on pack-year smoking history. Up to three telephone contact attempts will be made within two weeks. | Behavioural | Outreach arm |
Primary outcome
Proportion of individuals completing low-dose CT (LDCT) within 15 months of randomization.
Time frame: Within 15 months of randomization
4 secondary outcomes
LDCT scan findings: Lung Imaging Reporting and Data System (Lung-RADS)
Time frame: Within 15 months of randomization
LDCT incident findings
Time frame: Within 15 months of randomization
Follow-up care
Time frame: Within 6 months after screening
Average costs of implementing centralized outreach per individual
Time frame: Within 15 months of randomization
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 10 Dec 2025.
- Individual participant dataSharing planned: Yes. De-identified data collected during the trial.
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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.
Jialin Mao, MD, PhD principal investigator
Weill Medical College of Cornell University
Bradley B Pua, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Centralized patient outreach for lung cancer screening in people with Lung Cancer Screening, run by Weill Medical College of Cornell University at 1 site in United States.
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 6 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: enrolling by invitation, as of the sponsor's last update on 10 Dec 2025. 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 United States. 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?
Proportion of individuals completing low-dose CT (LDCT) within 15 months of randomization. (time frame: Within 15 months of randomization). 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 10 Dec 2025.