Clinical trial NCT04922541: Multi-center Observational Study on the Progression of Atherosclerotic Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up
Official title: Multi-center Observational Study on the Progression of Atherosclerotic Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Plaque, Atherosclerotic
Programmed Cell Death Protein 1 Inhibitor
Keywords: atherosclerotic plaque
PD-1 inhibitor
artery ultrasound
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Zhejiang Cancer Hospital
name: The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
name: Sun Yat-sen University
name: Ningbo Medical Center Lihuili Hospital
name: Ningbo No.2 Hospital
name: Huizhou Municipal Central Hospital
First posted: 2021-06-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population are the PD-1 inhibitor treated tumor patients from selected multi-center.

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sizes of plaque areas at the same locations on artery ultrasound
timeFrame: at least of 3 months after the first dosage of anti-PD-1 mAbs
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine at Zhejiang University
state: Zhejiang
Study officials:
References: