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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05123287
Other study ID # 2019-221
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 8, 2021
Est. completion date December 1, 2022

Study information

Verified date October 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Jianan Wang, MD, PhD
Phone +86 0571 87784808
Email wangjianan111@zju.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


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.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
PD-1 immune checkpoint blockades
intravenous injection; frequency: 2-3 weeks/cycle; duration: 3 months

Locations

Country Name City State
China The Second Affiliated Hospital of Zhejiang University, School of Medicine Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (8)

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Outcome

Type Measure Description Time frame Safety issue
Primary The mean intima-media thickness of the common carotid artery 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). 3 months
Primary The maximum intima-media thickness of the internal carotid artery 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. 3 months
Primary Carotid plaque burden 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. 3 months
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