The Detection of Small Early Liver Cancer With Natural History Follow up

Обзор

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.

Вмешательства

• Другое Blood & Urine Samples
  Blood and urine samples will be collected to help identify biomarkers that can be used to detect liver cancer at the earliest possible time
• Другое Imaging
  MRI \& MRE Scans

Первичные конечные точки

• Biomarkers associated with small HCC (Early detection [EDx] biomarkers) [Срок оценки: Throughout study to completion; up to 5 years]

Вторичные конечные точки (3)

• Prognostic ability of Early Detection (EDx) bio-markers [Срок оценки: Throughout study to completion; up to 5 years]
• Whether combinations of EDx tests improve the diagnostic and prognostic performance [Срок оценки: Throughout study to completion; up to 5 years]
• Proportion of patients with HCC events according to time since treatment with curative intent. [Срок оценки: Throughout study to completion; up to 5 years]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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
• 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)
• Participants of the Pearl study
• 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).

Exclusion Criteria for Imaging Subgroup

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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Великобритания · 1 центр

• Hepatology Clinical Trial Unit, John Radcliffe Hospital — Oxford

Идентификаторы

NCT: NCT05534906 · SELINA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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