A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05123287
Collaborator
(none)
50
1
13.8
3.6

Study Details

Study Description

Brief Summary

A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up

Detailed Description

This is a perspective, self-controlled cohort study. This study aims to evaluate the effectiveness of anti-PD-1 mAbs (PD-1 immune checkpoint blockades) on atherosclerotic carotid plaques in those anti-PD-1 mAbs treated patients. The method for quantification and evaluation of atherosclerotic plaques are based on the: ① The mean intima-media thickness of the common carotid artery (Mean CCA thickness); ② The maximum intima-media thickness of the internal carotid artery (maximum ICA thickness); ③ Carotid plaque burden: by calculation of the plaque area of atherosclerotic plaques on the long axis direction of artery on the ultrasound images. By comparing the above-mentioned parameters at the same location of carotid artery in each patient when initiate the first-dose of anti-PD-1 mAbs therapy and 3 months post anti-PD-1 mAbs therapy. It is designed to assess the effectiveness of anti-PD-1 mAbs on the progression of carotid plaques.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up
Actual Study Start Date :
Oct 8, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Outcome Measures

Primary Outcome Measures

  1. The mean intima-media thickness of the common carotid artery [3 months]

    It was measured over a segment of the common carotid artery that was 1 cm long, located approximately 0.5 cm below the carotid-artery bulb, and considered not to contain any plaque (i.e., not to have any perceivable protrusion of the artery wall into the lumen).

  2. The maximum intima-media thickness of the internal carotid artery [3 months]

    It was defined as the greatest intima-media thickness in either the right or left internal carotid artery extending from the bulb to 1 cm above the carotid sinus, ascertained from a total of four views on each side.

  3. Carotid plaque burden [3 months]

    Carotid plaque area measured by ultrasound (cross-sectional area of longitudinal views of all plaques seen) to quantify the increase or decrease of atherosclerotic carotid plaques.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  1. The age of subjects are between 18-90 years old (including 18 and 90 years old);

  2. All kinds of tumor diseases of subjects are acceptable;

  3. All kinds of PD-1 immune checkpoint blockades or dosages are acceptable;

  4. The subjects knew about the experiment and signed the informed consent voluntarily;

  5. The subjects plan to receive PD-1 immune checkpoint blockades and potentially to be treated for over 3 months;

  6. The subjects complicated with atherosclerotic carotid plaques.

Exclusion Criteria:
  1. Subjects stop receiving or changing the PD-1 immune checkpoint blockades during follow-up;

  2. Subjects are reluctant to continue to be involved in this study;

  3. Known pregnant and lactating women;

  4. The parameters (e.g., CCA intima-media, ICA intima-media or carotid plaque burden) could not be calculated because of the quality of ultrasound image;

  5. Other situations that the researchers judged were not suitable for inclusion.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Second Affiliated Hospital of Zhejiang University, School of Medicine Hangzhou Zhejiang China 310003

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Jianan Wang, MD, PhD, 2nd Affiliated Hospital, School of Medicine at Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05123287
Other Study ID Numbers:
  • 2019-221
First Posted:
Nov 17, 2021
Last Update Posted:
Nov 17, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2021