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Trial Title:
Study of Peripheral Arterial Disease (PAD) in People With Cancer Who Will Be Having Surgery
NCT ID:
NCT05754944
Condition:
Peripheral Arterial Disease (PAD) in Cancer Patients
Conditions: Official terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Conditions: Keywords:
Peripheral arterial disease (PAD)
Cancer patients
22-326
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
ABI/TBI
Description:
ABI/TBI to be performed after surgery while patient is still admitted at the hospital.
Arm group label:
Cancer patients having surgery
Intervention type:
Other
Intervention name:
Questionnaires
Description:
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.
Arm group label:
Cancer patients having surgery
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
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yolanda Bryce, MD
Phone:
212-639-6530
Start date:
February 22, 2023
Completion date:
February 2025
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Collaborator:
Agency:
BMS Foundation
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05754944
http://www.mskcc.org/mskcc/html/44.cfm
