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UnknownNCT05123287

A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up

Status
Unknown
Phase
—
Study type
Observational
Enrollment
50 (estimated)
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
—

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

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.

Conditions

Interventions

TypeNameDescription
DRUGPD-1 immune checkpoint blockadesintravenous injection; frequency: 2-3 weeks/cycle; duration: 3 months

Timeline

Start date
2021-10-08
Primary completion
2022-06-01
Completion
2022-12-01
First posted
2021-11-17
Last updated
2021-11-17

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05123287. Inclusion in this directory is not an endorsement.