Plaque, AtheroscleroticNCT04922541
Multi-center Observational Study on the Progression of Atherosclerotic Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up
An observational study of Plaque, Atherosclerotic and Programmed Cell Death Protein 1 Inhibitor, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Multi-center Observational Study on the Progression of Atherosclerotic Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Plaque, Atherosclerotic, Programmed Cell Death Protein 1 Inhibitor
- What is being tested?
- PD-1 inhibitor
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Study population are the PD-1 inhibitor treated tumor patients from selected multi-center.
Who may be able to join
- The age is 18-90 years old (including 18 and 90 years old);
- The subjects knew about the experiment and signed the informed consent voluntarily;
- The subjects complicated with tumor diseases and atherosclerotic plaques;
- The subjects received regular PD-1 inhibitor treatment;
- The subjects had ultrasound images of atherosclerotic plaques before- and after- or during PD-1 blockade treatment at the two different timepoints;
- The subjects received regular treatments of PD-1 inhibitor during the two timepoints of artery ultrasound examinations;
- The subjects who had ultrasound images before the initiation of first-dose PD-1 inhibitor, the interval between these two timepoints should be restricted within 1 month;
- The subjects who had ultrasound images after 3 months of PD-1 inhibitor treatment.
Who cannot join
- Subjects stop receiving PD-1 inhibitor treatments during follow-up;
- Subjects are reluctant to continue to be involved in this study; Known pregnant and lactating women;
- Plaque areas can not be calculated because of the quality of ultrasound image;
- Other situations that the researchers judged were not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine at Zhejiang University
Hangzhou, Zhejiang, 310009
Lin Fan, PhD, +13656691938, fanlin@zju.edu.cn
Jianan Wang, MD, PhD
About this study
Multi-center Observational Study on the Progression of Atherosclerotic Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up
Read the detailed description
This is a self-control, multi-center observational study. This study aims to evaluate the effectiveness of anti-PD-1 mAbs on atherosclerotic plaques in those anti-PD-1 mAbs treated patients. The method for quantification and evaluation of atherosclerotic plaques are based on the calculation of the plaque area of atherosclerotic plaques on the long axis direction of artery on the ultrasound images. By comparing the plaque areas at the same location of artery in each patient before and after anti-PD-1 mAbs treatments, to assess the progression of atherosclerotic plaques response to anti-PD-1 mAbs.
- Being tested
- PD-1 inhibitor
- Keywords
- atherosclerotic plaque, PD-1 inhibitor, artery ultrasound
- Medical subject headings
- Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 inhibitorDrug
dosage form: intravenous injection; frequency: 2-3 weeks; duration: at least 3 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Sizes of plaque areas at the same locations on artery ultrasound
Comparison of the sizes of plaque areas at the same locations on artery ultrasound before and after anti-PD-1 mAbs treatments.
Measured: at least of 3 months after the first dosage of anti-PD-1 mAbs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Nov 2019
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque, AtheroscleroticStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, Sun Yat-sen University, Ningbo Medical Center Lihuili Hospital, Ningbo No.2 Hospital, Huizhou Municipal Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922541
- Sponsor's protocol ID
- #2019-221
- Status last verified
- Jun 2021
- First submitted
- 5 Jun 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Observational Study on the Progression of Atherosclerotic Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up
- ClinicalTrials.gov ID
- NCT04922541
- Acronym / sponsor ID
- #2019-221
- Keywords
- atherosclerotic plaque, PD-1 inhibitor, artery ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, Sun Yat-sen University, Ningbo Medical Center Lihuili Hospital, Ningbo No.2 Hospital, Huizhou Municipal Central Hospital
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-center Observational Study on the Progression of Atherosclerotic Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up
Detailed description
This is a self-control, multi-center observational study. This study aims to evaluate the effectiveness of anti-PD-1 mAbs on atherosclerotic plaques in those anti-PD-1 mAbs treated patients. The method for quantification and evaluation of atherosclerotic plaques are based on the calculation of the plaque area of atherosclerotic plaques on the long axis direction of artery on the ultrasound images. By comparing the plaque areas at the same location of artery in each patient before and after anti-PD-1 mAbs treatments, to assess the progression of atherosclerotic plaques response to anti-PD-1 mAbs.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study population are the PD-1 inhibitor treated tumor patients from selected multi-center.
Key inclusion criteria (8 listed)
- The age is 18-90 years old (including 18 and 90 years old);
- The subjects knew about the experiment and signed the informed consent voluntarily;
- The subjects complicated with tumor diseases and atherosclerotic plaques;
- The subjects received regular PD-1 inhibitor treatment;
- The subjects had ultrasound images of atherosclerotic plaques before- and after- or during PD-1 blockade treatment at the two different timepoints;
Key exclusion criteria (4 listed)
- Subjects stop receiving PD-1 inhibitor treatments during follow-up;
- Subjects are reluctant to continue to be involved in this study; Known pregnant and lactating women;
- Plaque areas can not be calculated because of the quality of ultrasound image;
- Other situations that the researchers judged were not suitable for inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD-1 inhibitordosage form: intravenous injection; frequency: 2-3 weeks; duration: at least 3 months | Drug | – |
Primary outcome
Sizes of plaque areas at the same locations on artery ultrasound
Time frame: at least of 3 months after the first dosage of anti-PD-1 mAbs
Comparison of the sizes of plaque areas at the same locations on artery ultrasound before and after anti-PD-1 mAbs treatments.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque, Atherosclerotic and Programmed Cell Death Protein 1 Inhibitor, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianan Wang, MD, PhD (+86 0571 87784808, wangjianan111@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sizes of plaque areas at the same locations on artery ultrasound (time frame: at least of 3 months after the first dosage of anti-PD-1 mAbs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.