Peripheral Vascular Disease as a Clinical Trigger for Opportunistic Lung Cancer Screening Referral: An Implementation Study

Sponsor
International Agency for Research on Cancer
Study ID
NCT07598279
Status
Not Yet Recruiting

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Conditions

  • Ankle Brachial Index
  • Low Dose Computed Tomography
  • Lung Cancer
  • Peripheral Vascular Diseases

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Observational - low dose computed tomography scan — PROCEDURE
    Low dose CT scan for the standard screening arm
  • Experimental - low dose computed tomography scan — PROCEDURE
    low dose CT scan for the expanded screening group

Study Details

The study aims to determine whether patients with peripheral vascular disease who attend the vascular clinics are eligible for lung cancer screening. This is because long-term cigarette smoking exposure is associated with peripheral vascular disease, and smoking is again the main risk factor for lung cancer. These clinical encounters provide a potential opportunity to identify individuals who may qualify for lung cancer screening but are not routinely assessed for screening eligibility. Integrating systematic screening eligibility assessment within vascular clinics could therefore represent an effective strategy for identifying high-risk individuals and improving referral for lung cancer screening. Additionally, peripheral arterial disease is commonly diagnosed using the ankle-brachial index (ABI), a non-invasive measure that compares systolic blood pressure between the ankle and brachial arteries. An ABI value below 0.90 is widely recognised as diagnostic of peripheral arterial disease and reflects the presence of systemic atherosclerosis. ABI has been increasingly recognized as a marker of cumulative exposure to cardiovascular risk factors, particularly long-term tobacco smoking. Tobacco smoking contributes to endothelial dysfunction, chronic inflammation, and atherosclerotic plaque formation, mechanisms that are also implicated in lung carcinogenesis. Because both lung cancer and peripheral vascular disease share major risk factors, ABI may serve as a clinical proxy indicator of cumulative smoking-related vascular damage. Individuals with lower ABI values may therefore represent a subgroup with higher cumulative tobacco exposure and potentially elevated lung cancer risk. Evaluating the association between ABI severity categories and lung cancer diagnosis may provide insights into whether vascular disease severity could help identify individuals who may benefit from targeted screening interventions. If an association is observed, ABI could potentially be used as a simple, routinely measured clinical indicator to prompt lung cancer screening assessment in vascular care settings. Therefore, this study will determine the proportion of the vascular disease patients who fall under the high-risk group for lung cancer screening and refer them to low-dose CT scan and follow-up them for the results and the adherence.

Key Dates

First listed
May 20, 2026
Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
355 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Active Comparator: Standard screening protocol arm
    Patients eligible as per the USPSTF high-risk age and smoking history
  • Experimental: Expanded screening group arm
    Patients with expanded high-risk group: beyond the USPSTF recommendation - 40 years age and above and those with more than 15 pack-years smoking history, not quit in last 15 years

Primary Outcome Measure

Proportion of peripheral vascular disease patients who are eligible for lung cancer screening (as per standard screening recommendations - USPSTF) [ Time Frame: 6 months ]

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