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

Impact and Prevalence of PAD on Cancer Patients at High-risk for PAD Going to Surgery

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

Study Overview

• Status: Active, not recruiting
• Conditions: Peripheral Arterial Disease (PAD) in Cancer Patients
• Intervention / Treatment: Diagnostic test: ABI/TBI; Other: Questionnaires

• Study Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

65 years or older with either diabetes (requiring medication or insulin) or a smoking history (current smoker, smoker within the last 15 years, ≥ 20 year pack history), facing major head and neck, thoracic, abdominal, or pelvic surgery requiring at least at 2-day admission.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Cancer patients having surgery; 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

Diagnostic test: ABI/TBI; ABI/TBI to be performed after surgery while patient is still admitted at the hospital.; Other: Questionnaires; PAD symptoms questionnaire to be administered at baseline before surgery. mLEFS (included in PAD symptoms questionnaire) and WIQ to be administered at baseline before surgery. mLEFS and WIQ will be administered 1 month, 3 months, 6 months after surgery and every 6 months after that for a goal of at least 1 year.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: BMS Foundation
• Investigators: Principal Investigator: Yolanda Bryce, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cancer patients; Peripheral arterial disease (PAD); 22-326
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 22-326

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No