CASCAP is a prospective cohort study. Two cohorts have been defined, one for determining who should be screened and the other for patients diagnosed as having CCA. The screening cohort, characterized in the upper zone of Fig. 1, is expected to include at least 150,000 individuals coming from high-risk areas for CCA, including the self-enrolment of persons who feel that they are in danger of developing CCA. The inclusion criteria include all endemic northeastern Thais of 40 years or over with any of the following: ever been infected by or treated for liver flukes or known to have eaten uncooked freshwater fish with scales. Once consent has been obtained, the participants will be enrolled in the program and their baseline information collected. If CCA has been diagnosed, the individual will automatically be moved to the second, patient cohort, characterized in the lower zone of Fig. 1.
Workflow of the Cholangiocarcinoma Screening and Car Program (CASCAP). CCA = cholangiocarcinoma, U/S = ultrasonography, CT = computed tomography, MRI = magnetic resonance imaging, MRCP = magnetic resonance cholangiopancreatography
After the baseline characteristics have been recorded, an ultrasound examination will be carried out (the upper zone of Fig. 1) to determine whether there is current bile duct and/or liver pathology. Patients with liver mass or bile duct dilatation will be directed to confirmatory diagnostic tests and, if CCA is confirmed, they will be transferred to the patient cohort (the lower zone of Fig. 1). The patient cohort will include all CCA patients diagnosed in the region over a 5-year duration, with an estimated number of 5000 histologically proven new cases per year or 25,000 in the five-year recruitment period. It will include individuals diagnosed from the screening cohort, as well as new patients diagnosed at the nine tertiary-care hospitals participating in the CASCAP study. After diagnosis, the treatment regime will be determined and recorded. These patients will be treated according to the routine care procedures of the hospitals. Follow-up treatment will be recorded. Patients will be followed-up until the end of life.
Known to have eaten uncooked freshwater fish with scales
dependent variables
Whether there is current bile duct and/or liver pathology
Confirmation of cholangiocarcinoma (CCA) diagnosis
Treatment regime
Follow-up treatment
control variables
Endemic northeastern Thais of 40 years or over
controls
Positive control: Individuals diagnosed with CCA from the screening cohort
Negative control: Not explicitly mentioned
Annotations
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