Detection of High Expression Levels of EMT-Transcription Factor mRNAs in Patients With Pancreatic Cancer and Their Diagnostic Potential
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ClinicalTrials.gov Identifier: NCT04323917 |
Recruitment Status :
Recruiting
First Posted : March 27, 2020
Last Update Posted : August 10, 2020
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Condition or disease | Intervention/treatment |
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Pancreatic Cancer | Diagnostic Test: Liquid biopsy |
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.
Study Type : | Observational |
Estimated Enrollment : | 850 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Detection of High Expression Levels of EMT-Transcription Factor mRNAs in Patients With Pancreatic Cancer and Their Diagnostic Potential |
Actual Study Start Date : | November 2, 2017 |
Estimated Primary Completion Date : | November 2021 |
Estimated Study Completion Date : | November 2022 |

Group/Cohort | Intervention/treatment |
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Cases
Subjects affected by Pancreatic carcinoma (PC) confirmed by tissue biopsy
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Diagnostic Test: Liquid biopsy
Detection and quantification of EMT-transcription factor mRNA levels in blood |
Controls
Healthy Subject enrolled following colon cancer screening via colonoscopy
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Diagnostic Test: Liquid biopsy
Detection and quantification of EMT-transcription factor mRNA levels in blood |
- Assessments of diagnosis of PC by EMT-TF mRNA levels in blood [ Time Frame: Analysis at day 0: at diagnosis or before surgery for PC patients; before colonoscopy in controls ]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.
- Prediction of prognosis of PC by EMT-TF mRNA levels in blood [ Time Frame: Analysis at least: 7-15 days from surgery (T1), 30 days (T2) from surgery, 6 months (T3) from surgery, 1 year (T4) from surgery ]To identify biomarkers suitable for the selection of PC patients amenable of responsiveness to medical and surgical treatment.
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
This is a prospective pathological and molecular study of screening for pancreatic cancer. The main objectives of the trial are:
- To develop a specific and reproducible assay for the detection pancreatic cancer based on blood RNA and to amplify cancer specific molecular markers using qPCR.
- To correlate the presence of molecular markers in the samples with the presence of pancreatic cancer or pre-cancerous lesions.
- To add additional biomarkers to the study panel of biomarkers. presence of colon cancer or pre-cancerous lesions. To add additional biomarkers to the study panel of biomarkers.
Inclusion Criteria:
- Males or females over 18 years of age capable of providing informed consent.
- Pancreatic carcinoma confirmed by tissue biopsy or colon mass, clinically consistent with cancer and eventually confirmed by pathology.
- Subject were enrolled following colon cancer screening via colonoscopy
Exclusion Criteria:
- Patients under the age of 18 years or over the age of 80 years.
- Patients with personal history of cancer, identification of large polyp or adenomatous pathology on previous or subsequent colonoscopy
- Patient with history of abdominal surgery within the past four months
- Patients unwilling to or unable to give informed consent.
- Patients with acute inflammatory diseases or under any emergency condition.
- Pregnant women.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323917
Contact: Luigi AG Laghi, MD, PhD | 02 8224 ext 4572 | luigi.laghi@humanitas.it | |
Contact: Luana Greco, MD, MSci | luana.greco@humanitasresearch.it |
Italy | |
Istituto Clinico humanitas | Recruiting |
Milan, Italy, 20089 | |
Contact: Luigi Laghi, MD +390282244572 luigi.laghi@humanitas.it | |
Principal Investigator: Luigi Laghi, MD |
Responsible Party: | Istituto Clinico Humanitas |
ClinicalTrials.gov Identifier: | NCT04323917 |
Other Study ID Numbers: |
EMT PC 1.1 |
First Posted: | March 27, 2020 Key Record Dates |
Last Update Posted: | August 10, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Data patent covered. No. Patent: EP13197367.9 - December 16, 2013 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Epithelial to Mesenchymal Transition EMT PC mRNA |
EMT-TF Diagnosis Biomarkers Liquid biopsy |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |