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

Second Affiliated Hospital, School of Medicine, Zhejiang University50 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Plaque, Atherosclerotic Immune Checkpoint Inhibitors Programmed Cell Death Protein 1 Inhibitor Carotid Artery Plaque

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. The age of subjects are between 18-90 years old (including 18 and 90 years old); 2. All kinds of tumor diseases of subjects are acceptable; 3. All kinds of PD-1 immune checkpoint blockades or dosages are acceptable; 4. The subjects knew about the experiment and signed the informed consent voluntarily; 5. The subjects plan to receive PD-1 immune checkpoint blockades and potentially to be treated for over 3 months; 6. The subjects complicated with atherosclerotic carotid plaques. Exclusion Criteria: 1. Subjects stop receiving or changing the PD-1 immune checkpoint blockades during follow-up; 2. Subjects are reluctant to continue to be involved in this study; 3. Known pregnant and lactating women; 4. 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; 5. Other situations that the researchers judged were not suitable for inclusion.

Outcomes

Primary Outcomes

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).

Time frame: 3 months

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.

Time frame: 3 months

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.

Time frame: 3 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts