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Enrolling by Invitation

NCT Number: NCT07216144

Centralized Lung Cancer Screening Engagement in At-Risk Populations

This study will assess the impact of centralized outreach on lung cancer screening completion among individuals served by Federally Qualified Health Centers.

Enrolling by Invitation

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Centralized patient outreach for lung cancer screening

Behavioral

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.

Primary outcomes

  1. Proportion of individuals completing low-dose CT (LDCT) within 15 months of randomization.

    Time frame: Within 15 months of randomization

Secondary outcomes

  1. LDCT scan findings: Lung Imaging Reporting and Data System (Lung-RADS)

    Time frame: Within 15 months of randomization

    Proportion of individuals with Lung-RADS 1, 2, 3, and 4

  2. LDCT incident findings

    Time frame: Within 15 months of randomization

    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)

  3. Follow-up care

    Time frame: Within 6 months after screening

    Proportion of individuals receiving a biopsy or lung cancer treatment

  4. Average costs of implementing centralized outreach per individual

    Time frame: Within 15 months of randomization

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

Centralized Lung Cancer Screening Engagement in At-Risk Populations (CLEAR)

Acronym: CLEAR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 14, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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