Study of Peripheral Arterial Disease (PAD) in People With Cancer Who Will Be Having Surgery

Recruiting

• Conditions: Peripheral Arterial Disease (PAD) in Cancer Patients
• Interventions: Diagnostic Test: ABI/TBI; Other: Questionnaires

• Registration Number: NCT05754944
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

Researchers are studying whether people with risk factors for blood circulation disease have a condition called peripheral arterial disease (PAD). People with PAD have poor blood circulation because of narrowing or blocks in blood vessels caused by fat or calcium deposits (atherosclerosis). The study researchers think that PAD may lead to worse outcomes in cancer treatment, but people with cancer are not routinely tested for the disease.

The purpose of this study is to find out how common PAD is among people with cancer who have risk factors for blood circulation disease, and to compare how often PAD is diagnosed in different racial groups

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-22
• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-02-22
• Study First Posted: 2023-03-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-04
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Cancer patients who are ≥ 65 years old
• Either diabetes (on medication or insulin) or smoking history (current smoker, smoking within the last 15 years, ≥ 20 pack years)
• Patients who are scheduled for major head and neck, thoracic, abdominal, or pelvic surgery requiring at least a 2-day admission
• Ambulatory
• ≥ 6 month life expectancy as determined based on clinical judgement by the treating physician. If treating clinician does not confirm life-expectancy ≥ 6 months, will calculate Lee Schoenberg Index using ePrognosis.ucsf.edu.

Exclusion Criteria

• Hospice patient, patient with a DNR order
• Non-ambulatory, wheelchair/bed bound
• < 6 month life expectancy based on the clinical judgement by the treating physician

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer patients having surgery	ABI/TBI	This is a prospective cohort study where patients who are 65 years or older with either a history of diabetes (requiring medication or insulin) or smoking history (current smoker, smoker within the last 15 years, or ≥ 20 year pack history), facing major head and neck, thoracic, abdominal, or pelvic surgery will be screened for PAD with an ABI/TBI to establish prevalence and to compare prevalence among races to meet
Cancer patients having surgery	Questionnaires	This is a prospective cohort study where patients who are 65 years or older with either a history of diabetes (requiring medication or insulin) or smoking history (current smoker, smoker within the last 15 years, or ≥ 20 year pack history), facing major head and neck, thoracic, abdominal, or pelvic surgery will be screened for PAD with an ABI/TBI to establish prevalence and to compare prevalence among races to meet

Primary Outcome Measures

Name	Time	Method
prevalence of PAD in cancer patients at high-risk for PAD going to surgery	1 year	Completion of ABI/TBI to be able to assess prevalence of PAD

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States