Can pancreatic cancer be detected by adrenomedullin in patients with new-onset diabetes? The PaCANOD cohort study protocol.

INTRODUCTION: Pancreatic cancer is a leading cause of cancer-related death. Its diagnosis is often delayed and patients are frequently found to have unresectable disease. Patients diagnosed with new-onset diabetes have an 8-fold risk of harboring pancreatic cancer. Adrenomedullin has been claimed to mediate diabetes in pancreatic cancer. New screening tools are needed to develop an early diagnosis protocol.

METHODS: Patients aged 45-75 years within 2 years of first fulfilling the ADA criteria for diabetes will be prospectively enrolled in this study. Sepsis, renal failure, microangiopathy, pregnancy, acute heart failure and previous malignancies will be considered as exclusion criteria.

RESULTS: 440 patients diagnosed with new-onset diabetes will be enrolled and divided into 2 groups: one with high adrenomedullin levels and one with low adrenomedullin levels. Patients will undergo 3 years' follow-up to detect pancreatic cancer development.

CONCLUSIONS: Identifying a marker for pancreatic cancer among high-risk patients such as new-onset diabetics might lead to the identification of a subpopulation needing to be screened in order to enable early diagnosis and treatment of a highly lethal tumor.

TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov on May 25, 2015 under registration number NCT02456051.