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

NCT07598279 | Not Yet Recruiting

• 1 other identifier: PVD-Lungs
• Study Type: interventional
• Target: 355
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

lung cancer; peripheral vascular disease; ankle brachial index; low dose computed tomography; lung cancer screening; opportunistic screening

Outcome Measures

Primary Outcomes (1)

• Proportion of peripheral vascular disease patients who are eligible for lung cancer screening (as per standard screening recommendations - USPSTF)

  6 months

Secondary Outcomes (1)

• Proportion of peripheral vascular disease patients who are screened for lung cancer by LDCT as per the expanded eligibility criteria

  6 months

Study Arms (2)

Standard screening protocol arm

ACTIVE COMPARATOR

Patients eligible as per the USPSTF high-risk age and smoking history

Procedure: Observational - low dose computed tomography scan

Expanded screening group arm

EXPERIMENTAL

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

Procedure: Experimental - low dose computed tomography scan

Interventions

Observational - low dose computed tomography scan PROCEDURE

Low dose CT scan for the standard screening arm

Standard screening protocol arm

Experimental - low dose computed tomography scan PROCEDURE

low dose CT scan for the expanded screening group

Expanded screening group arm

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients known/suspected to have peripheral vascular disease attending specified clinics in the tertiary care hospital

You may not qualify if:

• Prior diagnosis of lung cancer established/on work-up
• Patients with no smoking history
• Patients not eligible for low-dose CT scan

Sponsors & Collaborators

• International Agency for Research on Cancer: lead

Study Sites (1)

Indira Gandhi Government General Hospital and Post Graduate Institute

Puducherry, India

Location

MeSH Terms

Conditions

Lung Neoplasms; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ravivarman LAKSHMANASAMY

  International Agency for Research on Cancer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Public Health Officer / Researcher

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

IN (1)