Ignite Creation Date:
2024-05-06 @ 2:27 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04323917
Status:
UNKNOWN
Last Update Posted:
2020-08-10
First Post:
2019-12-20
Brief Title:
Detection of High Expression Levels of EMT-Transcription Factor mRNAs in Patients With Pancreatic Cancer and Their Diagnostic Potential
Sponsor:
Istituto Clinico Humanitas
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
Detection of High Expression Levels of EMT-Transcription Factor mRNAs in Patients With Pancreatic Cancer and Their Diagnostic Potential
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study is aimed at detecting and measuring mRNA levels of genes involved in epithelial to mesenchymal transition EMT in biological samples ie in peripheral blood samples of pancreatic cancer PC patients and healthy controls to determine the presence of disease its progression and risk of recurrence
Detailed Description:
The investigators first provided evidence that human pancreatic cancer PC cells can undergo EMT during local invasion and that EMT transcription factors ieTwist 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 patientsThese 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 ie 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
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 patientsThese 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None