Pancreatic Cancer Clinical Trial
Official title:
Detection of High Expression Levels of EMT-Transcription Factor mRNAs in Patients With Pancreatic Cancer and Their Diagnostic Potential
The present study is aimed at detecting and measuring mRNA levels of genes involved in epithelial to mesenchymal transition (EMT) in biological samples, i.e. in peripheral blood samples of pancreatic cancer (PC) patients and healthy controls, to determine the presence of disease, its progression and risk of recurrence.
The investigators first provided evidence that human pancreatic cancer (PC) cells can undergo
EMT during local invasion, and that EMT transcription factors (i.e.Twist family basic
helix-loop-helix transcription factor 1 (TWIST1)) are increased in the blood of PC patients.
In addressing the relevance of EMT in the metastatic process, the prognostic role of M-like
cancer cells entering into the circulation remains to be determined.
Currently, the notion that cancer disseminates via the circulation led to increased attention
on the identification of circulating tumor cells (CTCs) in blood samples ("liquid biopsy";
LB), so far exclusively based upon epithelial (E) markers. However, an un-biased evaluation
of CTCs, providing meaningful information for cancer diagnosis up to therapy, cannot exclude
cells with M features. LB data show that circulating TWIST1, zinc finger E-box binding
homeobox 2 (ZEB2) and E-Cadherin (CDH1) messenger ribonucleic acids (mRNA) are significantly
and steadily increased in the blood of PC patients.These findings indicate that high levels
of EMT players in the circulation efficiently discriminate PC patients, irrespectively of
tumor resectability.
The present study is aimed at detecting and measuring mRNA levels of genes involved in
epithelial to mesenchymal transition in biological samples, i.e. in peripheral blood samples
of tumor patients, to determine the presence of disease, its progression and risk of
recurrence.
Aim of the study is to depict the molecular profile of EMT-Transcription factor (EMT-TFs)
variations in the blood of patients with early, intermediate or advanced PC, with respect to
disease progression and delivered treatments.
Primary endpoint: to determ the stage, the remission or the progression of a pancreatic
cancer in a pancreatic cancer affected subjects. This end-point comprising the step of
assaying a biological sample from said subject for the presence of a panel of mRNAs encoding
for transcription factors involved in epithelial to mesenchymal transition.
Secondary endpoint: to identify biomarkers suitable for the selection of patients amenable of
responsiveness to medical and surgical treatment.
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