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

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

NCT ID: NCT05549336

Condition: Carotid Artery Plaque
Pd-1 Inhibitors

Conditions: Official terms:
Carotid Stenosis
Immune Checkpoint Inhibitors

Study type: Observational [Patient Registry]

Overall status: Unknown status

Study design:

Time perspective: Prospective

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

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.

Criteria for eligibility:

Study pop:
All tumor patients who are initiating the chemotherapy in The Second Affiliated Hospital, Zhejiang University School of Medicine (SAHZU) and willing to join this cohort study after the date of recruiting (19th Sep 2022). These patients who are eligible for the inclusion criteria would be the targets for further follow-up.

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

Locations:

Facility:
Name: The Second Affiliated Hospital of Zhejiang University, School of Medicine

Address:
City: Hangzhou
Zip: 310000
Country: China

Status: Recruiting

Contact:
Last name: Jianan Wang, MD, PhD

Phone: +86 0571 87784808
Email: wangjianan111@zju.edu.cn

Contact backup:
Last name: Lin Fan, PhD

Phone: +86 13656691938
Email: fanlin@zju.edu.cn

Start date: September 16, 2022

Completion date: September 30, 2023

Lead sponsor:
Agency: Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class: Other

Source: Second Affiliated Hospital, School of Medicine, Zhejiang University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05549336