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

NCT05549336 | Unknown

• 1 other identifier: 2022-0803
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Plaque; Pd-1 Inhibitors

Outcome Measures

Primary Outcomes (3)

• Carotid plaque area

  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.

  3 months

• The mean intima-media thickness of the common carotid artery

  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).

  3 months

• The maximum intima-media thickness of the internal carotid artery

  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 months

Study Arms (2)

PD-1-treated tumor patients

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

Drug: PD-1 inhibitor

non-PD-1-treated tumor patients

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

Interventions

PD-1 inhibitor 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.

Also known as: PD-1 immune checkpoint blockades

PD-1-treated tumor patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Subjects know about the experiment and signed the informed consent voluntarily; and
• Subjects are tumor patients and all kinds of tumor diseases of subjects are acceptable; and
• Subjects are initiating to receive chemotherapy; and
• Subjects are diagnosed with atherosclerotic carotid plaques by ultrasound examination at the timepoint of the first-dose treatment; and

You may not qualify if:

• Subjects stop receiving or changing the existing chemotherapy during follow-up; or
• Subjects are reluctant to continue to be involved in this study; or
• Subjects are known pregnant and lactating women; or
• Subjects are not complicated with atherosclerotic carotid plaques at the timepoint of the first-dose treatment; or

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 12468791 BACKGROUND

• 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.

  PMID: 22541275 BACKGROUND

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

  PMID: 25686472 BACKGROUND

• 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.

  PMID: 26493239 BACKGROUND

• 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.

  PMID: 21774709 BACKGROUND

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Jianan Wang, MD, PhD

  2nd Affiliated Hospital, School of Medicine at Zhejiang University

  STUDY CHAIR

• Lin Fan, PhD

  2nd Affiliated Hospital, School of Medicine at Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianan Wang, MD, PhD

CONTACT

+86 0571 87784808; wangjianan111@zju.edu.cn

Lin Fan, PhD

CONTACT

+86 13656691938; fanlin@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2022
• First Posted: September 22, 2022
• Study Start: September 16, 2022
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: September 22, 2022

Record last verified: 2022-09

Locations

CN (1)