Multi-center Observational Study on the Progression of Atherosclerotic Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up

Zhejiang University

Status: Unknown

Conditions: Programmed Cell Death Protein 1 Inhibitor; Plaque, Atherosclerotic

Treatments: Drug: PD-1 inhibitor

Study type: Observational

Funder types: Other

Identifiers

NCT04922541

#2019-221

Details and patient eligibility

About

Multi-center Observational Study on the Progression of Atherosclerotic Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up

Full description

This is a self-control, multi-center observational study. This study aims to evaluate the effectiveness of anti-PD-1 mAbs on atherosclerotic plaques in those anti-PD-1 mAbs treated patients. The method for quantification and evaluation of atherosclerotic plaques are based on the calculation of the plaque area of atherosclerotic plaques on the long axis direction of artery on the ultrasound images. By comparing the plaque areas at the same location of artery in each patient before and after anti-PD-1 mAbs treatments, to assess the progression of atherosclerotic plaques response to anti-PD-1 mAbs.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The age is 18-90 years old (including 18 and 90 years old);
2. The subjects knew about the experiment and signed the informed consent voluntarily;
3. The subjects complicated with tumor diseases and atherosclerotic plaques;
4. The subjects received regular PD-1 inhibitor treatment;
5. The subjects had ultrasound images of atherosclerotic plaques before- and after- or during PD-1 blockade treatment at the two different timepoints;
6. The subjects received regular treatments of PD-1 inhibitor during the two timepoints of artery ultrasound examinations;
7. The subjects who had ultrasound images before the initiation of first-dose PD-1 inhibitor, the interval between these two timepoints should be restricted within 1 month;
8. The subjects who had ultrasound images after 3 months of PD-1 inhibitor treatment.

Exclusion criteria

1. Subjects stop receiving PD-1 inhibitor treatments during follow-up;
2. Subjects are reluctant to continue to be involved in this study; Known pregnant and lactating women;
3. Plaque areas can not be calculated because of the quality of ultrasound image;
4. Other situations that the researchers judged were not suitable for inclusion.