NCT06084078

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
53mo left

Started Sep 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Sep 2024Aug 2030

First Submitted

Initial submission to the registry

September 27, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2030

Last Updated

April 24, 2026

Status Verified

April 1, 2025

Enrollment Period

5 years

First QC Date

September 27, 2023

Last Update Submit

April 21, 2026

Conditions

Keywords

cancer screeningLDCTLung cancer

Outcome Measures

Primary Outcomes (2)

  • Screening rate

    Percentage of individuals screened (completed CT imaging) with and without telehealth

    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

    Through study completion, an average of 1 year

Secondary Outcomes (3)

  • Time to treatment initiation

    Through study completion, an average of 1 year

  • Adherence to Screening

    Through study completion, an average of 1 year

  • Cost

    Through study completion, an average of 1 year

Study Arms (2)

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

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • All individuals 50-80 years of age
  • pack-year smoking history
  • Currently smoke or have quit within the past 15 years:

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sowmy Thuppal

Springfield, Illinois, 62704, United States

RECRUITING

Related Publications (2)

  • 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.

  • National 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.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sowmy Thuppal, MD PhD

    Southrn Illinois University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sowmy Thuppal, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 16, 2023

Study Start

September 1, 2024

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 31, 2030

Last Updated

April 24, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

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.

Locations