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Spots Global Cancer Trial Database for Validation of SMS Protocol for HCC Screening in High-risk Patients

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Trial Identification

Brief Title: Validation of SMS Protocol for HCC Screening in High-risk Patients

Official Title: Validation of a Short and Effective MRI Surveillance (SMS) Protocol for Hepatocellular Carcinoma Screening in Practice

Study ID: NCT05429190

Study Description

Brief Summary: The investigators will assess implementation of the proposed SMS protocol as a surveillance tool in patients at high risk of developing HCC in a prospective multicenter study.

Detailed Description: Over the past 20 years, the prevalence of HCC has been growing extensively. HCC makes up for 75-85% of primary liver cancers and has a poor prognosis with a 5-year survival rate lower than 20%. The incidence of HCC is higher in patients diagnosed with hepatitis and/or cirrhosis. The current guidelines recommend a bi-annual US screening of this patient group. However, recent meta-analysis showed that the sensitivity of such US surveillance for detecting early stage HCC is merely 47%. In addition, early detection of small HCC lesions (with a diameter less than 2 cm) will provide a higher survival chance. It is therefore of major importance to develop a better surveillance tool. The use of MRI should be considered as a surveillance tool for this patient group. In comparison to US, MRI come with high cost, long duration of the scan, limited availability and a potential risk related to the use of contrast agents. The investigators have developed and validated a short MRI surveillance (SMS) protocol for HCC screening in high-risk patients. This protocol has been evaluated among a database of 215 patients. In this prospective, multicenter study, the investigators will evaluate the value of the SMS protocol in a high-risk patient group and they will assess the cost-effectiveness of the SMS protocol as a surveillance tool with respect to a bi-annual US screening.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Academic Medical Center, Amsterdam, Noord-Holland, Netherlands

Medisch Spectrum Twente, Enschede, Overijssel, Netherlands

Albert Schweitzer Ziekenhuis, Dordrecht, Zuid-Holland, Netherlands

Erasmus Medical Center, Rotterdam, Zuid-Holland, Netherlands

St. Franciscus Gasthuis & Vlietland, Rotterdam, Zuid-Holland, Netherlands

Maasstad Ziekenhuis, Rotterdam, Zuid-Holland, Netherlands

Contact Details

Name: Prof. Dr. de Man

Affiliation: Erasmus Medical Center

Role: PRINCIPAL_INVESTIGATOR

Name: Dr. Takkenberg

Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Role: PRINCIPAL_INVESTIGATOR

Name: Prof. Dr. Uyl-de Groot

Affiliation: Erasmus School of Health Policy & Management Rotterdam

Role: PRINCIPAL_INVESTIGATOR

Name: Prof. Dr. IJzermans

Affiliation: Erasmus Medical Center

Role: PRINCIPAL_INVESTIGATOR

Name: Dr. Bos

Affiliation: Erasmus Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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