Clinical trial · Observational
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
NCT05549336CI-TRIAL-00060998unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carotid Artery Plaque | — | UNRESOLVED | — |
| Pd-1 Inhibitors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- PD-1-treated tumor patients
- description
- Tumor patients who are initiating receive chemotherapy that includes PD-1 inhibitors.
- interventionNames
- Drug: PD-1 inhibitor
- label
- non-PD-1-treated tumor patients
- description
- Tumor patients who are initiating receive chemotherapy that not includes PD-1 inhibitors.
Primary outcomes (3)
- measure
- Carotid plaque area
- timeFrame
- 3 months
- description
- 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.
- measure
- The mean intima-media thickness of the common carotid artery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDSpence 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
- BACKGROUNDLorenz 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
- BACKGROUNDSpence 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
- BACKGROUNDLechareas 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
- BACKGROUNDPolak 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