Single-center, Prospective Cohort Study of PD-1 Inhibitors on Clinical Outcomes of Carotid Plaques in Tumor Patients

Single-center, Prospective Cohort Study of PD-1inhibitors on Clinical Outcomes of Carotid Plaques in Tumor Patients

Sponsors

Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Brief Summary

This is a single-center, prospective cohort study on the comparison of clinical outcomes of carotid plaques in PD-1-treated tumor patients vs non-PD-1-treated tumor patients.

Detailed Description

Atherosclerosis, a chronic inflammatory disorder, leads to cardio-cerebrovascular diseases, causing most of the global deaths. The chronic and non-resolved inflammatory responses of both innate and adaptive immune cells are involved in the all-stage pathogenesis of atherosclerosis. The impairment of inflammatory resolution promotes atherogenesis and causes instability of atherosclerotic plaques. Their subsequent rupture would induce severe cardio-cerebrovascular incidences (e.g., acute myocardial infarction and ischemic strokes). Recent progress in anti-inflammatory immunotherapies on human atherosclerosis opens the door to resolving this inflammatory disorder by targeting the immune system. However, the impacts of PD-1 immune checkpoint blockades on the progressions of human carotid plaques are not determined yet. This is a prospective cohort study, which aims to evaluate the effectiveness of PD-1 immune checkpoint blockades on atherosclerotic carotid plaques in tumor patients in comparison to those with non-PD-1-treated tumor patients. The method for quantification and evaluation of atherosclerotic plaques are based on: (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 areas: 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 the carotid artery in the patients when initiating the first dose of anti-PD-1 or non-PD-1 chemotherapy and 3 months after anti-PD-1 or non-PD-1 chemotherapy. It is designed to assess the effectiveness of PD-1 immune checkpoint blockades or non-PD-1 chemotherapy on the clinical prognosis of carotid plaques after a period of 3-month treatment.

Overall Status Recruiting
Start Date 2022-09-16
Completion Date 2023-09-30
Primary Completion Date 2023-06-30
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Carotid plaque area 3 months
The mean intima-media thickness of the common carotid artery 3 months
The maximum intima-media thickness of the internal carotid artery 3 months
Enrollment 100
Condition
Intervention

Intervention Type: Drug

Intervention Name: PD-1 inhibitor

Description: PD-1 inhibitor is defined as the exposure factor in our cohort study, for the tumor patients with the treatment of PD-1 inhibitor are allocated to the Exposure group whereas those tumor patients without the treatment of PD-1 inhibitor are allocated to the Non-exposure group.

Arm Group Label: PD-1-treated tumor patients

Other Name: PD-1 immune checkpoint blockades

Eligibility

Sampling Method:

Probability Sample

Criteria:

Inclusion Criteria: 1. Subjects know about the experiment and signed the informed consent voluntarily; and 2. Subjects are tumor patients and all kinds of tumor diseases of subjects are acceptable; and 3. Subjects are initiating to receive chemotherapy; and 4. Subjects are diagnosed with atherosclerotic carotid plaques by ultrasound examination at the timepoint of the first-dose treatment; and Exclusion Criteria: 1. Subjects stop receiving or changing the existing chemotherapy during follow-up; or 2. Subjects are reluctant to continue to be involved in this study; or 3. Subjects are known pregnant and lactating women; or 4. Subjects are not complicated with atherosclerotic carotid plaques at the timepoint of the first-dose treatment; or 4. The parameters (e.g., CCA intima-media, ICA intima-media, or carotid plaque area) could not be calculated because of the quality of the ultrasound image; or 5. Other situations that the researchers judged are not suitable for further inclusion.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Overall Contact

Last Name: Jianan Wang, MD, PhD

Phone: +86 0571 87784808

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: The Second Affiliated Hospital of Zhejiang University, School of Medicine Jianan Wang, MD, PhD +86 0571 87784808 [email protected]
Location Countries

China

Verification Date

2022-09-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: PD-1-treated tumor patients

Description: Tumor patients who are initiating receive chemotherapy that includes PD-1 inhibitors.

Label: non-PD-1-treated tumor patients

Description: Tumor patients who are initiating receive chemotherapy that not includes PD-1 inhibitors.

Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carotid Artery Plaque

Clinical Trials on PD-1 inhibitor