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

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

Study Overview

• Status: Recruiting
• Conditions: Plaque, Atherosclerotic; Programmed Cell Death Protein 1 Inhibitor
• Intervention / Treatment: Drug: PD-1 inhibitor

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine at Zhejiang University
      • Principal Investigator: Jianan Wang, MD, PhD
      • Contact: Lin Fan, PhD; Phone Number: +13656691938; Email: fanlin@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population are the PD-1 inhibitor treated tumor patients from selected multi-center.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: June 5, 2021
• First Submitted That Met QC Criteria: June 5, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 5, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: PD-1 inhibitor; atherosclerotic plaque; artery ultrasound
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Plaque, Atherosclerotic; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immune Checkpoint Inhibitors
• Other Study ID Numbers: #2019-221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No