TRACER Qualitative Interviews
Factors Influencing Biomarker-Based Surveillance for Liver Cancer
Lauren Nephew
Primary Investigator
Brief description of study
The purpose of this study is to better understand what influences the adoption of the emerging modality of biomarker-based HCC surveillance, opposed to the currently accepted standard of image-based HCC surveillance. The primary aim will be to identify and describe what motivates or prevents a patient from moving to biomarker-based HCC surveillance.
Participants with HCC (hepatocellular cancer) who see a Hepatology provider at the Digestive and Livers Disorders Clinic at University Hosptial will be recruited for this study in person during their clinic appointmen or will be called by a member of the study staff via telephone prior to the appointment.
Detailed description of study
This is a qualitative study that will utilize semi-structured interviews to collect data from TRACER eligible patients.
- After enrollment, participants will take part in one interview, which will consist of open-ended questions, via phone or in person, for an estimated 30-minute duration.
- Participants will be asked their feelings about clinical trials and research in general and then asked about barriers against or reasons for research participation. After the close of the interview, study participation is completed.
- With participant permission, interviews will be recorded so that they may be transcribed. All transcripts will be de-identified.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Hepatocellular carcinoma, HCC, Cirrhosis, Hepatitis, Chronic hepatitis B
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Age: 18 years - 85 years
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Gender: All
Inclusion Criteria
• patients who were eligible to participate in the parent HCC study, TRACER
• willing and able to provide consent
• adult patients ages 18-85 with cirrhosis or with chronic hepatitis B with a PAGE-B score greater than 9 within 12 months prior to consent
• patient is eligible for HCC surveillance according to treating physician or by the site
investigator
• able to provide informed consent
• life expectancy >6 months (after consent) as determined by the treating provider or site investigator
Exclusion Criteria
• unwilling or unable to provide consent
• Child Pugh C
• History or clinical symptoms of hepatocellular carcinoma or cholangiocarcinoma
• History of solid nodule on baseline ultrasound (i.e., lesion 1cm or greater) within 9 months prior to consent without subsequent diagnostic CT/MRI demonstrating benign nature)
• AFP >20 ng/mL within 6 months prior to consent, in the absence of a contrast-enhanced
• CT or MRI within 6 months of AFP (before or after) level demonstrating lack of suspicious liver lesions
• Newly diagnosed LR-3 greater than or equal to 1 cm within 6 months prior to consent
• History of LR-4, LR-5, or LR-M on multi-phase CT or contrast-enhanced MRI within 6
months prior to consent
• Presence of another active cancer besides non-melanomatous skin cancer or indolent
cancer under active surveillance (e.g., prostate cancer or renal cell carcinoma) within the 2 years prior to consent
• Patient’s provider is planning to use MRI- or CT- based surveillance moving forward
• History of a transjugular intrahepatic portosystemic shunt (TIPS)
• History of Fontan associated liver disease or cardiac cirrhosis
• History of solid organ transplantation
• Actively listed for liver transplantation
• Diagnosis of alcohol-associated hepatitis within 3 months prior to consent
• Documented current or continued signs and symptoms of acute Wilson disease (acute
liver failure, acute neurological deficits, hemolysis)
• In patients with primary sclerosing cholangitis (PSC): Current active cholangitis within 90
days prior to consent
• Known or documented habitual non-adherence to previous research studies or medical
• procedures or unwillingness to adhere to protocol (e.g., unwilling to obtain consent or
samples)
• In patients living with HIV: CD4+ T cell count less than 100 cells/mm3 within 60 days prior to consent
• Known pregnancy at consent
• Active warfarin use
This study investigates what influences patients to choose biomarker-based surveillance for liver cancer instead of the standard image-based method. Hepatocellular cancer, or HCC, is a type of liver cancer. The study aims to understand the motivations or barriers for patients when deciding on this new type of surveillance.
Participants will have one interview, either by phone or in person, lasting about 30 minutes. During this interview, they will answer open-ended questions about their feelings on clinical trials and research. With permission, the interviews will be recorded and later transcribed without identifying information. Once the interview is complete, the study participation ends.
- Who can participate: Adults aged 18-85 with cirrhosis or chronic hepatitis B and a PAGE-B score over 9 are eligible. Participants must be eligible for HCC surveillance and have a life expectancy of more than 6 months.
- Study details: Participants will be interviewed about their views on clinical trials and barriers to participation. Interviews will be recorded if permitted, and transcripts will be anonymized. After the interview, participation is complete.
- Study visits: The study requires 1 visits.
