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
1 other identifier
observational
114
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2023
CompletedStudy Start
First participant enrolled
February 22, 2023
CompletedFirst Posted
Study publicly available on registry
March 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
March 4, 2026
March 1, 2026
3.9 years
February 22, 2023
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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
Interventions
ABI/TBI to be performed after surgery while patient is still admitted at the hospital.
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BMS Foundationcollaborator
- Memorial Sloan Kettering Cancer Centerlead
Study Sites (1)
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yolanda Bryce, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2023
First Posted
March 6, 2023
Study Start
February 22, 2023
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
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.