A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up
Study Details
Study Description
Brief Summary
A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
This is a perspective, self-controlled cohort study. This study aims to evaluate the effectiveness of anti-PD-1 mAbs (PD-1 immune checkpoint blockades) on atherosclerotic carotid plaques in those anti-PD-1 mAbs treated patients. The method for quantification and evaluation of atherosclerotic plaques are based on the: ① The mean intima-media thickness of the common carotid artery (Mean CCA thickness); ② The maximum intima-media thickness of the internal carotid artery (maximum ICA thickness); ③ Carotid plaque burden: by calculation of the plaque area of atherosclerotic plaques on the long axis direction of artery on the ultrasound images. By comparing the above-mentioned parameters at the same location of carotid artery in each patient when initiate the first-dose of anti-PD-1 mAbs therapy and 3 months post anti-PD-1 mAbs therapy. It is designed to assess the effectiveness of anti-PD-1 mAbs on the progression of carotid plaques.
Study Design
Outcome Measures
Primary Outcome Measures
- The mean intima-media thickness of the common carotid artery [3 months]
It was measured over a segment of the common carotid artery that was 1 cm long, located approximately 0.5 cm below the carotid-artery bulb, and considered not to contain any plaque (i.e., not to have any perceivable protrusion of the artery wall into the lumen).
- The maximum intima-media thickness of the internal carotid artery [3 months]
It was defined as the greatest intima-media thickness in either the right or left internal carotid artery extending from the bulb to 1 cm above the carotid sinus, ascertained from a total of four views on each side.
- Carotid plaque burden [3 months]
Carotid plaque area measured by ultrasound (cross-sectional area of longitudinal views of all plaques seen) to quantify the increase or decrease of atherosclerotic carotid plaques.
Eligibility Criteria
Criteria
Inclusion Criteria:
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The age of subjects are between 18-90 years old (including 18 and 90 years old);
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All kinds of tumor diseases of subjects are acceptable;
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All kinds of PD-1 immune checkpoint blockades or dosages are acceptable;
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The subjects knew about the experiment and signed the informed consent voluntarily;
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The subjects plan to receive PD-1 immune checkpoint blockades and potentially to be treated for over 3 months;
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The subjects complicated with atherosclerotic carotid plaques.
Exclusion Criteria:
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Subjects stop receiving or changing the PD-1 immune checkpoint blockades during follow-up;
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Subjects are reluctant to continue to be involved in this study;
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Known pregnant and lactating women;
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The parameters (e.g., CCA intima-media, ICA intima-media or carotid plaque burden) could not be calculated because of the quality of ultrasound image;
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Other situations that the researchers judged were not suitable for inclusion.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | The Second Affiliated Hospital of Zhejiang University, School of Medicine | Hangzhou | Zhejiang | China | 310003 |
Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
- Principal Investigator: Jianan Wang, MD, PhD, 2nd Affiliated Hospital, School of Medicine at Zhejiang University
Study Documents (Full-Text)
None provided.More Information
Publications
- O'Leary DH, Polak JF, Kronmal RA, Manolio TA, Burke GL, Wolfson SK Jr. Carotid-artery intima and media thickness as a risk factor for myocardial infarction and stroke in older adults. Cardiovascular Health Study Collaborative Research Group. N Engl J Med. 1999 Jan 7;340(1):14-22.
- Spence JD. Measurement of carotid plaque burden. JAMA Neurol. 2015 Apr;72(4):383-4. doi: 10.1001/jamaneurol.2014.3002. Review.
- 2019-221