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2017-11-02
2021-11
2022-11
850
NCT04323917
Istituto Clinico Humanitas
Istituto Clinico Humanitas
OBSERVATIONAL
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-12-20 | N/A | 2020-08-07 |
2020-03-24 | N/A | 2020-08-10 |
2020-03-27 | N/A | 2020-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Cases Subjects affected by Pancreatic carcinoma (PC) confirmed by tissue biopsy | DIAGNOSTIC_TEST: Liquid biopsy
|
| : Controls Healthy Subject enrolled following colon cancer screening via colonoscopy | DIAGNOSTIC_TEST: Liquid biopsy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Assessments of diagnosis of PC by EMT-TF mRNA levels in blood | To determine the stage, the remission or the progression of a pancreatic cancer in a pancreatic cancer affected subject not administered with an appropriate antitumor treatment (e.g., neo-adjuvant therapy) 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. | Analysis at day 0: at diagnosis or before surgery for PC patients; before colonoscopy in controls |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Prediction of prognosis of PC by EMT-TF mRNA levels in blood | To identify biomarkers suitable for the selection of PC patients amenable of responsiveness to medical and surgical treatment. | Analysis at least: 7-15 days from surgery (T1), 30 days (T2) from surgery, 6 months (T3) from surgery, 1 year (T4) from surgery |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Luigi AG Laghi, MD, PhD Phone Number: 02 8224 Email: luigi.laghi@humanitas.it |
Study Contact Backup Name: Luana Greco, MD, MSci Phone Number: Email: luana.greco@humanitasresearch.it |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
