Lung CancerLDCTNCT06084078
Rural Illinois Lung Cancer Screening Initiative
An observational study of Lung Cancer, run by Southern Illinois University at 1 site in United States.
Trial summary
The role of this observational study is to access the feasibility of providing lung cancer screening using a designated nurse navigator through lung cancer screening clinic. Eligible participants will be identified using medical records, eligibility will be confirmed through phone call, screening visits will be… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Lung Cancer
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 31 Aug 2030
- How long will I take part?
- 30 Years
- 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 50 to 80 years
- All sexes
- Adult, Older adult
Study population: The risk of lung cancer increases with age and smoking status and hence this age range is recommended for receiving lung cancer screening. As per USPSTF criteria our screening initiative will include individuals 50-80 years, subjects of all sex/gender and all race/ethnic groups. Screening eligible individuals included in our pilot study consisted of 54.4 % women, 75% of non-Hispanic whites, 24% non-Hispanic blacks and 1.2% belonged to 'other' race category. Non-Hispanic black individuals with smoking history have a higher risk of developing lung cancer than a non-Hispanic white. Very few Hispanic persons and women tend to accumulate fewer pack-years over a long period of time.
Who may be able to join
- All individuals 50-80 years of age
- 20 pack-year smoking history
- Currently smoke or have quit within the past 15 years:
Who cannot join
- Individuals 49 years and below or 81 years and above
- Has not smoked in 15 or more years
- Individuals who develop a health problem that makes them unwilling or unable to have surgery if lung cancer is detected.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sowmy Thuppal
Springfield, Illinois, 62704
sthuppal83@siumed.edu
About this study
Official title: Patient Identification, Prescreening and LDCT Screening for Lung Cancer With Telehealth
The role of this observational study is to access the feasibility of providing lung cancer screening using a designated nurse navigator through lung cancer screening clinic. Eligible participants will be identified using medical records, eligibility will be confirmed through phone call, screening visits will be scheduled as in-person visit or telehealth visit. Computed tomography screening will be performed at an approved center closer to the individuals place of living and results will be discussed during follow-up in-person visit or telehealth visit.
Read the detailed description
The long-term goal is to establish healthcare practices to increase adherence to lung cancer screening among high-risk individuals. The overall objective in this application is to establish a lung cancer screening initiative to proactively identify and screen eligible patients for LDCT using a designated nurse practitioner (NP) along with telehealth. The central hypothesis is that use of a designated NP along with telehealth will increase lung cancer screening via LDCT among high-risk, racial/ethnic minority, and rural/sub-urban patients. The rationale for this proposal is use of a NP and telehealth will help overcome the barriers physicians face in identifying eligible patients for LDCT including collecting additional information to determine eligibility, discussing the pros and cons of LDCT, providing smoking cessation/abstinence counseling, making shared decisions, and documenting this information in the patients' charts.
In this prospective cohort study the nurse practitioner (NP) will proactively identify eligible individuals for LDCT using EMRs that are shared across the Department of Family and Community Medicine at SIU. These patients will be contacted and those agreeing to undergo screening will be given a referral to a nearby LDCT center. The NP will follow-up with the patients with the results of the LDCT and will refer them for further management to their primary care physician. If the results are negative for nodules then they will be followed up on a yearly basis until the participants are older than 80 years or have other life-threatening health issues.
- Conditions
- Lung Cancer
- Keywords
- cancer screening, LDCT, Lung cancer
- Medical subject headings
- Lung Neoplasms
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 |
|---|---|---|
| Telehealth cohort | Individuals who opt to do the screening using telehealth. Telehealth using video assisted techniques or using telephone. | |
| In-person cohort | Individuals who are willing to travel to the hospital for in-person screening and follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening rate
Percentage of individuals screened (completed CT imaging) with and without telehealth
Measured: Through study completion, an average of 1 year
Early stage diagnosis
Percentage of individuals diagnosed with lung cancer at an early stage of the disease
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Time to treatment initiation
Number of days from diagnosis to treatment initiation will be calculated for each patient diagnosed with lung cancer
Measured: Through study completion, an average of 1 year
Adherence to Screening
Percentage of of individuals undergoing yearly screening with and without telehealth
Measured: Through study completion, an average of 1 year
Cost
Overall cost from pre-screening to screening and follow-up with and without telehealth
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start1 Sep 2024
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- 10,000 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- Southern Illinois University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sowmy Thuppal, MD PhD, Principal investigator, Southrn Illinois University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084078
- Sponsor's protocol ID
- LDCT Screening
- Acronym
- LDCT
- Status last verified
- Apr 2025
- First submitted
- 27 Sep 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The goal of this project is to look a at telehealth vs in-person screening. Overall aggregates will be shared with the scientific community to assess if telehealth is a better option for screening.
Publications
Thuppal S, Hendren JR, Colle J, Sapra A, Bhandari P, Rahman R, Krus-Johnston A, Hoffman MR, Foray N, Hazelrigg S, Crabtree T. Proactive Recruitment Strategy for Patient Identification for Lung Cancer Screening. Ann Fam Med. 2023 Mar-Apr;21(2):119-124. doi: 10.1370/afm.2905.
PubMed 36973046National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
PubMed 21714641
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Identification, Prescreening and LDCT Screening for Lung Cancer With Telehealth
- ClinicalTrials.gov ID
- NCT06084078
- Acronym / sponsor ID
- LDCT / LDCT Screening
- Conditions
- Lung Cancer
- Keywords
- cancer screening, LDCT, Lung cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Southern Illinois UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 16 Oct 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.
The role of this observational study is to access the feasibility of providing lung cancer screening using a designated nurse navigator through lung cancer screening clinic. Eligible participants will be identified using medical records, eligibility will be confirmed through phone call, screening visits will be scheduled as in-person visit or telehealth visit. Computed tomography screening will be performed at an approved center closer to the individuals place of living and results will be discussed during follow-up in-person visit or telehealth visit.
Detailed description
The long-term goal is to establish healthcare practices to increase adherence to lung cancer screening among high-risk individuals. The overall objective in this application is to establish a lung cancer screening initiative to proactively identify and screen eligible patients for LDCT using a designated nurse practitioner (NP) along with telehealth. The central hypothesis is that use of a designated NP along with telehealth will increase lung cancer screening via LDCT among high-risk, racial/ethnic minority, and rural/sub-urban patients. The rationale for this proposal is use of a NP and telehealth will help overcome the barriers physicians face in identifying eligible patients for LDCT including collecting additional information to determine eligibility, discussing the pros and cons of LDCT, providing smoking cessation/abstinence counseling, making shared decisions, and documenting this information in the patients' charts.
In this prospective cohort study the nurse practitioner (NP) will proactively identify eligible individuals for LDCT using EMRs that are shared across the Department of Family and Community Medicine at SIU. These patients will be contacted and those agreeing to undergo screening will be given a referral to a nearby LDCT center. The NP will follow-up with the patients with the results of the LDCT and will refer them for further management to their primary care physician. If the results are negative for nodules then they will be followed up on a yearly basis until the participants are older than 80 years or have other life-threatening health issues.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth cohort | – | –Individuals who opt to do the screening using telehealth. Telehealth using video assisted techniques or using telephone. |
| In-person cohort | – | –Individuals who are willing to travel to the hospital for in-person screening and follow-up |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The risk of lung cancer increases with age and smoking status and hence this age range is recommended for receiving lung cancer screening. As per USPSTF criteria our screening initiative will include individuals 50-80 years, subjects of all sex/gender and all race/ethnic groups. Screening eligible individuals included in our pilot study consisted of 54.4 % women, 75% of non-Hispanic whites, 24% non-Hispanic blacks and 1.2% belonged to 'other' race category. Non-Hispanic black individuals with smoking history have a higher risk of developing lung cancer than a non-Hispanic white. Very few Hispanic persons and women tend to accumulate fewer pack-years over a long period of time.
Key inclusion criteria (3 listed)
- All individuals 50-80 years of age
- 20 pack-year smoking history
- Currently smoke or have quit within the past 15 years:
Key exclusion criteria (3 listed)
- Individuals 49 years and below or 81 years and above
- Has not smoked in 15 or more years
- Individuals who develop a health problem that makes them unwilling or unable to have surgery if lung cancer is detected.
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
Screening rate
Time frame: Through study completion, an average of 1 year
Percentage of individuals screened (completed CT imaging) with and without telehealth
Early stage diagnosis
Time frame: Through study completion, an average of 1 year
Percentage of individuals diagnosed with lung cancer at an early stage of the disease
3 secondary outcomes
Time to treatment initiation
Time frame: Through study completion, an average of 1 year
Adherence to Screening
Time frame: Through study completion, an average of 1 year
Cost
Time frame: Through study completion, an average of 1 year
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 24 Apr 2026.
- Results publication: PubMed 36973046Thuppal S, Hendren JR, Colle J, Sapra A, Bhandari P, Rahman R, Krus-Johnston A, Hoffman MR, Foray N, Hazelrigg S, Crabtree T. Proactive Recruitment Strategy for Patient Identification for Lung Cancer Screening. Ann Fam Med. 2023 Mar-Apr;21(2):119-124. doi: 10.1370/afm.2905.
- Results publication: PubMed 21714641National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
- Individual participant dataSharing planned: No. The goal of this project is to look a at telehealth vs in-person screening. Overall aggregates will be shared with the scientific community to assess if telehealth is a better option for screening.
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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.
Sowmy Thuppal, MD PhD principal investigator
Southrn Illinois University School of Medicine
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 Southern Illinois 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 24 Apr 2026. 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?
Contact Sowmy Thuppal, MD PhD (217-545-2320, sthuppal83@siumed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening rate (time frame: Through study completion, an average of 1 year). 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?
On the ClinicalTrials.gov record for NCT06084078, which also lists 2 linked publications.
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 24 Apr 2026.