NCT05534906Recruiting
The Detection of Small Early Liver Cancer With Natural History Follow up
Source: ClinicalTrials.gov · Last updated 10 Sept 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The SELINA study will recruit 200 patients with cirrhosis and small HCC and 50 patients with HCC but without cirrhosis (most of whom are expected to have FLD). Blood, urine and liver tissue samples (where available) will be collected for laboratory analysis. In a subgroup of patients (N=80, around 64 patients with HCC with liver cirrhosis and around 16 patients with HCC without liver cirrhosis), additional magnetic resonance liver imaging will be performed. The findings of the SELINA study aim to identify biomarkers that can be used to detect liver cancer at the earliest possible time, something we expect will increase the survival rate of HCC.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 1 Aug 2022
- Start date
- 23 May 2022
- Primary completion date
- Jun 2035
- Lead sponsor
- University of Oxford
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05534906
What you commit to
- Study type: Observational
- Planned participants: 250
- From 23 May 2022 to the primary completion date, Jun 2035
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have had a previous liver transplant (note, it is permitted to enrol patients on the liver transplant waiting list if they fulfil all inclusion/exclusion criteria)
- Patients who have had a previous diagnosis of HCC followed by therapy, and now have a recurrence at the same site in the liver
- Patients who have received HCC specific therapy 3 months prior to study visit 1 (including resection, ablation \[microwave/radiofrequency\]), transarterial chemoembolization \[TACE\], select internal radiation therapy \[SIRT\] or stereotactic body radiation therapy \[SBRT\] 3, chemotherapy, immune modulators and other experimental therapies).
Other illness
- 1\. Any contra-indication to Magnetic Resonance Imaging (MRI) (e.g. claustrophobia, metal implants/fragments, implants, pregnancy, other conditions the scanner operator deems unsafe for MR scanning).
Other
- Patients judged by the investigator to be unsuitable for inclusion in the study (e.g. where the investigator feels that the participant will not be able to comply with the study procedures)
- HCC with liver cirrhosis at BCLC stage B/C
- Participants of the Pearl study
Who the study is looking for
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female aged 18 years or above.
- Diagnosed with small HCC (Barcelona Clinic Liver Cancer Staging Criteria (BCLC) stage 0/A; 1-3 nodules \<3cm, preserved liver function, performance status 0) with liver cirrhosis from any aetiology
- Diagnosed with small HCC (as above) and without cirrhosis
- Diagnosis of small HCC shown or confirmed within 3 months of study Visit 1
- Patients with a diagnosis of HCC that was fully ablated or resected more than 6 months ago and now presenting with a new diagnosis of HCC in a different site in the liver may be included in the study
- Histological confirmation is required to establish the diagnosis of HCC in patients without cirrhosis (imaging alone is not considered sufficient to establish the diagnosis of HCC).
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hepatology Clinical Trial Unit, John Radcliffe Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.