Clinical Research Directory

Sub-Study 1 Inclusion Criteria * Case Arm: * At the baseline visit, \>18 years old, any gender * At the baseline visit, available biospecimens for both EDTA-plasma and urine * Diagnosis of cancer before or at the baseline visit or diagnosis of cancer after the baseline visit * If a diagnosis of cancer before or at the baseline visit, then no antineoplastic treatment between the date of diagnosis and the baseline visit * Control Arm: * At the baseline visit, \>18 years old, any gender * Not receiving treatment for or under surveillance for cancer at the baseline visit * No indications of being monitored for or under consideration for suspected cancer at the baseline visit * No diagnosis of cancer before or on the baseline visit or if any previous diagnosis of cancer, then cancer must have been curatively treated ≥ 5 years before the baseline visit * No diagnosis of cancer within at least 365 days after the baseline visit * At the baseline visit, available biospecimens for both EDTA-plasma and urine * Exploratory Arm: * Same as Control Arm and type 2 diabetes or hypertension or BMI \> 30 at the baseline visit Exclusion Criteria * Case Arm: * No available data for diagnosis of cancer starting 90 days before the baseline visit and up to 365 days after the baseline visit * A subject with only a self-reported diagnosis of cancer (either in the 90 days before or in the 365 days after the baseline visit), and absence of a histopathological or clinically indicated diagnosis of cancer, according to biobank database(s), or through linkage with cancer registry(ies) * Control Arm and Exploratory Arm: * No available data for diagnosis of cancer up to 365 days after or on the baseline visit * A histopathological or clinically indicated diagnosis of cancer within 365 days from the baseline visit, according to biobank database(s), or through linkage with cancer registry(ies) Sub-Study 2 Inclusion Criteria * At the baseline visit, 35 - 80 years old, any gender * Not receiving treatment for or under surveillance for cancer at the baseline visit * No indications of being monitored for or under consideration for suspected cancer at the baseline visit * No diagnosis of cancer before or on the baseline visit or if any previous diagnosis of cancer, then cancer must have been curatively treated ≥ 5 years before the baseline visit * At the baseline visit, available biospecimens for both EDTA-plasma and urine Exclusion Criteria * No available data for diagnosis of cancer up to 365 days after the baseline visit * A subject with only a self-reported diagnosis of cancer in the 365 days after the baseline visit and absence of a histopathological or clinically indicated diagnosis of cancer, according to biobank database(s), or through linkage with cancer registry(ies) * Subjects not meeting the specifications for the target population eventually changed during test development in Sub-Study 1. Note that these specifications are pre-specified in the Statistical Analysis Plan and will be applied if they meet pre-specified acceptance criteria.