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Multi-center Observational Study on the Progression of Atherosclerotic 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
NCT04922541
Collaborator
Zhejiang Cancer Hospital (Other), The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China (Other), Sun Yat-sen University (Other), Ningbo Medical Center Lihuili Hospital (Other), Ningbo No.2 Hospital (Other), Huizhou Municipal Central Hospital (Other)
50
Enrollment
1
Location
37
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
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
Actual Study Start Date :
Nov 1, 2019
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Sizes of plaque areas at the same locations on artery ultrasound [at least of 3 months after the first dosage of anti-PD-1 mAbs]

    Comparison of the sizes of plaque areas at the same locations on artery ultrasound before and after anti-PD-1 mAbs treatments.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 2nd Affiliated Hospital, School of Medicine at Zhejiang University Hangzhou Zhejiang China 310009

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04922541
Other Study ID Numbers:
  • #2019-221
First Posted:
Jun 10, 2021
Last Update Posted:
Jun 10, 2021
Last Verified:
Jun 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
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
atherosclerotic plaque
PD-1 inhibitor
artery ultrasound
Additional relevant MeSH terms:
Plaque, Atherosclerotic
Immune Checkpoint Inhibitors

Study Results

No Results Posted as of Jun 10, 2021