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NCT Number: NCT05754944

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Peripheral Arterial Disease (PAD) in Cancer Patients Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABI/TBI

Diagnostic Test

ABI/TBI to be performed after surgery while patient is still admitted at the hospital.

questionnaires

Other

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.

Primary outcomes

  1. prevalence of PAD in cancer patients at high-risk for PAD going to surgery

    Time frame: 1 year

    Completion of ABI/TBI to be able to assess prevalence of PAD

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • BMS Foundation

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2023
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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