A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up
NCT ID: NCT05123287
Last Updated: 2021-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2021-10-08
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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PD-1 immune checkpoint blockades
intravenous injection; frequency: 2-3 weeks/cycle; duration: 3 months
Eligibility Criteria
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Inclusion Criteria
2. All kinds of tumor diseases of subjects are acceptable;
3. All kinds of PD-1 immune checkpoint blockades or dosages are acceptable;
4. The subjects knew about the experiment and signed the informed consent voluntarily;
5. The subjects plan to receive PD-1 immune checkpoint blockades and potentially to be treated for over 3 months;
6. The subjects complicated with atherosclerotic carotid plaques.
Exclusion Criteria
2. Subjects are reluctant to continue to be involved in this study;
3. Known pregnant and lactating women;
4. The parameters (e.g., CCA intima-media, ICA intima-media or carotid plaque burden) could not be calculated because of the quality of ultrasound image;
5. Other situations that the researchers judged were not suitable for inclusion.
18 Years
90 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Jianan Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
2nd Affiliated Hospital, School of Medicine at Zhejiang University
Locations
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The Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Lin Fan, PhD
Role: primary
References
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Spence JD. Measurement of carotid plaque burden. JAMA Neurol. 2015 Apr;72(4):383-4. doi: 10.1001/jamaneurol.2014.3002. No abstract available.
O'Leary DH, Polak JF, Kronmal RA, Manolio TA, Burke GL, Wolfson SK Jr. Carotid-artery intima and media thickness as a risk factor for myocardial infarction and stroke in older adults. Cardiovascular Health Study Collaborative Research Group. N Engl J Med. 1999 Jan 7;340(1):14-22. doi: 10.1056/NEJM199901073400103.
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.
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.
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.
Saba L, Saam T, Jager HR, Yuan C, Hatsukami TS, Saloner D, Wasserman BA, Bonati LH, Wintermark M. Imaging biomarkers of vulnerable carotid plaques for stroke risk prediction and their potential clinical implications. Lancet Neurol. 2019 Jun;18(6):559-572. doi: 10.1016/S1474-4422(19)30035-3. Epub 2019 Apr 4.
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.
Sakaguchi M, Kitagawa K, Nagai Y, Yamagami H, Kondo K, Matsushita K, Oku N, Hougaku H, Ohtsuki T, Masuyama T, Matsumoto M, Hori M. Equivalence of plaque score and intima-media thickness of carotid ultrasonography for predicting severe coronary artery lesion. Ultrasound Med Biol. 2003 Mar;29(3):367-71. doi: 10.1016/s0301-5629(02)00743-3.
Other Identifiers
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2019-221
Identifier Type: -
Identifier Source: org_study_id