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| Name | Class |
|---|---|
| BMS Foundation | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABI/TBI | Diagnostic Test | ABI/TBI to be performed after surgery while patient is still admitted at the hospital. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Yolanda Bryce, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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.
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| 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. |
|
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |