NCT04200534

Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)

Active, enrolled EARLY_PHASE1 Last updated 22 August 2025

What this trial tests

EARLY_PHASE1 trial testing Best Practice in Smoking in 358 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

31 July 2020

Primary endpoint
28 February 2027

28 February 2027

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	EARLY_PHASE1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	358
Start date	31 July 2020
Primary completion	28 February 2027
Estimated completion	28 February 2027
Sites	3 locations across United States

Drugs / interventions tested

• Best Practice
• Nicotine Patch (nicotine-patch) — full drug profile →
• Quality-of-Life Assessment
• Questionnaire Administration
• Tobacco Cessation Counseling

Conditions studied

• Smoking — all drugs for Smoking →
• Lung Cancer — all drugs for Lung Cancer →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Adults 55 to 77, any sex, with Smoking or Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial studies how well a centralized care strategy works in improving the quality of smoking cessation and shared decision making among patients who smoke and are considering lung cancer screening. The centralized care strategy is a model where smokers eligible for lung cancer screening are referred to a dedicated tobacco treatment program where they receive both the shared decision-making and initiate smoking cessation counseling prior to their visit with a primary care provider. Utilizing the centralized care model may work better in helping people quit smoking and make informed decisions about lung cancer screening compared to usual care.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Strategies to improve smoking cessation rates in primary care.
   Lindson N, Pritchard G, Hong B, Fanshawe TR, et al · · 2021 · cited 45× · PMID 34693994 · DOI 10.1002/14651858.cd011556.pub2
2. A protocol for a cluster randomized trial of care delivery models to improve the quality of smoking cessation and shared decision making for lung cancer screening.
   Lowenstein LM, Shih YT, Minnix J, Lopez-Olivo MA, et al · · 2023 · cited 2× · PMID 36878389 · DOI 10.1016/j.cct.2023.107141