Featured Research Program
CSP #2023
Local Site Investigators: Perica Davitkov, MD and Preet Kang, MD
Study Co-Chairs: George N. Ioannou, MD and Tamar H. Taddei, MD
Study Coordinator: Gjorgje Stojadinovikj
CSP #2023 study is multi-center research trial of surveillance for hepatocellular carcinoma (HCC). The study is also known as PREMIUM which stands for PREventing liver cancer Mortality through Imaging with Ultrasound vs. MRI. The goal of PREMIUM is to compare an abbreviated version of the diagnostic gold standard for HCC (aMRI) +AFP to the standard-of-care screening (US+AFP) in patients at high risk of developing HCC. We hypothesize that HCC will be detected at earlier stages, allowing for more curative treatments and resulting in a reduction in HCC-related mortality.
While specialty societies endorse ultrasound (US) for HCC screening in the cirrhosis population, the sensitivity and specificity of US to detect HCC at early stages is poor, and studies suggest there may be little survival benefit. A complete, multiphasic abdominal MRI is the current gold-standard diagnostic test for HCC and has excellent sensitivity and specificity. Complete, multiphasic MRI is time-consuming (30-45 minutes scanner time) and costly, which reduces its cost-effectiveness as a screening modality in patients with cirrhosis. Abbreviated MRI (aMRI) protocols have been developed for HCC screening that have a similarly high sensitivity and specificity to complete MRI but can be completed in a much shorter time (~15 minutes) thus making them more suitable for screening.
Study Design
We propose to conduct a randomized controlled trial of screening for hepatocellular carcinoma (HCC) by ultrasound (US)+serum alpha fetoprotein (AFP) every 6 months (the current standard-of-care) versus abbreviated MRI (aMRI)+AFP every 6 months among patients with cirrhosis who have a high risk of HCC.
Study rationale
- Screening by aMRI will detect earlier stage HCC, as compared to screening by US
- Patients with HCC diagnosed at earlier stages as a result of aMRI will be more likely to receive curative treatments resulting in lower HCC-related mortality
- aMRI protocols can be implemented at any VA facility with an MRI scanner and have a relatively low cost due to the short scanner time.
- Therefore, if our study demonstrates a decrease in HCC-related mortality as a result of aMRI screening, we expect screening by aMRI to become the new standard of care and to be adopted and implemented widely and quickly to transform HCC management.
Research Forums
Research forums will be held monthly. Our winter schedule is listed below. Presentations will be broadcast using MS Teams.
Tuesday, December 12 @ 12:30PM-2:00PM
Research Open House: Meet and greet with the Research Administration Team
This will be IN-PERSON in the VA Rec Hall. Refreshments will be served. Please save the date and plan on attending.
Tuesday, January 23 @ 1:00PM
VA Northeast Ohio Healthcare System- Research Updates, presented by Neal Peachey, Ph.D., Associate Chief of Staff/Research
Microsoft Teams meeting; Join on your computer, mobile app or room device
Meeting ID: 274 189 817 615 Passcode: qFJwSr
Click here to join the meeting
Tuesday, February 27 @ 1:00PM
Getting to know the Cleveland VA Research and Education Foundation (CVAREF) presented by, Jeffrey Moore, Ph.D., Executive Director and Marcie Denallo, Grants Manager
Tuesday, March 26 @ 1:00PM
Clinical Research Updates presented by, Margaret Tiktin, Director, Clinical Research Center.
Research Service Temporary Relocation
On December 15th, the Research Service will temporarily be moving to the 6th Floor of the EUL building Suite 62625
If you have any questions about this relocation, please contact Holly Henry holly.henry@va.gov
Research Compliance Office Updates
Research Compliance is going electronic! The Research Compliance Office will be requiring all informed consent audit submissions going forward to be electronic beginning November 1, 2023. Guidance is posted on the current physical submission box as well as in the chats from the October Office hours. We invite you to begin this process ASAP to work out any issues you may encounter prior to November 1st. If you do not have actual consents to send during this time, you may submit a test submission and describe it is a test in the body of the e-mail. If you need a copy, please feel free to reach out to the research compliance office.
A friendly reminder to ensure all submissions are appropriately encrypted prior to sending! Our office remains available for any questions you may have, please reach out to us on MS Teams or send us an e-mail. Thank you!
Office Hours (Research Compliance & Education)
Research Compliance Office & Research Service (Education) have an open forum via teams the 2nd & 4th Wednesday of each month from 12:30pm-1:00pm
During the office hours you can ask any questions that you may have about Research Compliance/Research Education.
If you have topics that you would like us to discuss in future office hours, please send an email to Jennifer Zindle jennifer.zindle@va.gov
Please use the link below to join us on Wednesday, December 6, 2023
Join on your computer, mobile app or room device
Click here to join the meeting
Meeting ID: 236 321 831 958 Passcode: HAvGVK
Study Initiation Visits
What is a Study Initiation Visit?
The study initiation visit encompasses a review of regulatory requirements as they apply to your specific study, good clinical practice guidelines, the informed consent and HIPAA documents as well as a review of how to maintain study records (regulatory binder and subject files).
The Research Compliance Office is required to perform a triennial regulatory audit of studies (human subjects' research, animal protocols, and basic science studies) and informed consent and HIPAA audits if applicable. The intent of a study initiation visit is to help the researcher avoid the most common audit findings before they occur.
Did you know that you can schedule a Study Initiation Visit with the Research Service?
The study initiation visit is available to all research staff. If you are new to research or need a refresher, you can schedule a study initiation visit today.
For scheduling or questions contact Candice Toney at Candice.Toney@va.gov or 216-791-3800 x66785.
Upcoming VA Research Funding Deadlines
The next round of VA Grant submissions will take place in March 2024 for BLR&D, CSR&D and RR&D SPiRE.
If you are considering an application, please reach out to Christine.Hendricks@va.gov for additional information.
Office of Research & Development
Upcoming Webinars: Office of Research Protections, Policy, and Education Webinars (va.gov)
Archived webinars can be found at: ORPP&E Webinar Archive (va.gov)
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