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

Plaque, Atherosclerotic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04922541
• Other study ID #: #2019-221
• Status: Recruiting
• Start date: November 1, 2019
• Est. completion date: December 2022

Study information

• Verified date: June 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
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Plaque, Atherosclerotic

Intervention

Drug:
• PD-1 inhibitor
dosage form: intravenous injection; frequency: 2-3 weeks; duration: at least 3 months

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine at Zhejiang University	Hangzhou	Zhejiang

Sponsors (7)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Huizhou Municipal Central Hospital, Ningbo Medical Center Lihuili Hospital, Ningbo No.2 Hospital, Sun Yat-sen University, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sizes of plaque areas at the same locations on artery ultrasound	Comparison of the sizes of plaque areas at the same locations on artery ultrasound before and after anti-PD-1 mAbs treatments.	at least of 3 months after the first dosage of anti-PD-1 mAbs