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

NCT ID: NCT05549336

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-16
• Study Completion Date: 2023-09-30

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.

Conditions

Carotid Artery Plaque; Pd-1 Inhibitors

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PD-1-treated tumor patients

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

PD-1 inhibitor

Intervention Type: DRUG

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.

non-PD-1-treated tumor patients

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

No interventions assigned to this group

Interventions

PD-1 inhibitor

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.

Intervention Type: DRUG

Other Intervention Names

PD-1 immune checkpoint blockades

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianan Wang, MD, PhD

Role: STUDY_CHAIR

2nd Affiliated Hospital, School of Medicine at Zhejiang University

Lin Fan, PhD

Role: PRINCIPAL_INVESTIGATOR

2nd Affiliated Hospital, School of Medicine at Zhejiang University

Locations

The Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianan Wang, MD, PhD

Role: CONTACT

wangjianan111@zju.edu.cn

+86 0571 87784808

Lin Fan, PhD

Role: CONTACT

fanlin@zju.edu.cn

+86 13656691938

Facility Contacts

Jianan Wang, MD, PhD

Role: primary

wangjianan111@zju.edu.cn

+86 0571 87784808

Lin Fan, PhD

Role: backup

fanlin@zju.edu.cn

+86 13656691938

References

Spence JD, Eliasziw M, DiCicco M, Hackam DG, Galil R, Lohmann T. Carotid plaque area: a tool for targeting and evaluating vascular preventive therapy. Stroke. 2002 Dec;33(12):2916-22. doi: 10.1161/01.str.0000042207.16156.b9.

Reference Type: BACKGROUND

PMID: 12468791 (View on PubMed)

Lorenz MW, Polak JF, Kavousi M, Mathiesen EB, Volzke H, Tuomainen TP, Sander D, Plichart M, Catapano AL, Robertson CM, Kiechl S, Rundek T, Desvarieux M, Lind L, Schmid C, DasMahapatra P, Gao L, Ziegelbauer K, Bots ML, Thompson SG; PROG-IMT Study Group. Carotid intima-media thickness progression to predict cardiovascular events in the general population (the PROG-IMT collaborative project): a meta-analysis of individual participant data. Lancet. 2012 Jun 2;379(9831):2053-62. doi: 10.1016/S0140-6736(12)60441-3. Epub 2012 Apr 27.

Reference Type: BACKGROUND

PMID: 22541275 (View on PubMed)

Spence JD. Measurement of carotid plaque burden. JAMA Neurol. 2015 Apr;72(4):383-4. doi: 10.1001/jamaneurol.2014.3002. No abstract available.

Reference Type: BACKGROUND

PMID: 25686472 (View on PubMed)

Lechareas S, Yanni AE, Golemati S, Chatziioannou A, Perrea D. Ultrasound and Biochemical Diagnostic Tools for the Characterization of Vulnerable Carotid Atherosclerotic Plaque. Ultrasound Med Biol. 2016 Jan;42(1):31-43. doi: 10.1016/j.ultrasmedbio.2015.09.003. Epub 2015 Oct 20.

Reference Type: BACKGROUND

PMID: 26493239 (View on PubMed)

Polak JF, Pencina MJ, Pencina KM, O'Donnell CJ, Wolf PA, D'Agostino RB Sr. Carotid-wall intima-media thickness and cardiovascular events. N Engl J Med. 2011 Jul 21;365(3):213-21. doi: 10.1056/NEJMoa1012592.

Reference Type: BACKGROUND

PMID: 21774709 (View on PubMed)

Other Identifiers

2022-0803

Identifier Type: -

Identifier Source: org_study_id