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

NCT04922541 | Unknown DMC

• 1 other identifier: #2019-221
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Plaque, Atherosclerotic; Programmed Cell Death Protein 1 Inhibitor

Keywords

atherosclerotic plaque; PD-1 inhibitor; artery ultrasound

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

PD-1 inhibitor DRUG

dosage form: intravenous injection; frequency: 2-3 weeks; duration: at least 3 months

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• The age is 18-90 years old (including 18 and 90 years old);
• The subjects knew about the experiment and signed the informed consent voluntarily;
• The subjects complicated with tumor diseases and atherosclerotic plaques;
• The subjects received regular PD-1 inhibitor treatment;
• The subjects had ultrasound images of atherosclerotic plaques before- and after- or during PD-1 blockade treatment at the two different timepoints;
• The subjects received regular treatments of PD-1 inhibitor during the two timepoints of artery ultrasound examinations;
• 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;
• The subjects who had ultrasound images after 3 months of PD-1 inhibitor treatment.

You may not qualify if:

• Subjects stop receiving PD-1 inhibitor treatments during follow-up;
• Subjects are reluctant to continue to be involved in this study; Known pregnant and lactating women;
• Plaque areas can not be calculated because of the quality of ultrasound image;

Sponsors & Collaborators

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

Study Sites (1)

2nd Affiliated Hospital, School of Medicine at Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Plaque, Atherosclerotic

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Jianan Wang, MD, PhD

CONTACT

+86 0571 87784808; wangjianan111@zju.edu.cn

Lin Fan, PhD

CONTACT

+86 13656691938; fanlin@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2021
• First Posted: June 10, 2021
• Study Start: November 1, 2019
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 10, 2021

Record last verified: 2021-06

Locations

CN (1)