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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 : Unknown
Verified August 2020 by Istituto Clinico Humanitas.
Recruitment status was:  Recruiting
First Posted : March 27, 2020
Last Update Posted : August 10, 2020
Sponsor:
Collaborator:
IRCCS San Raffaele
Information provided by (Responsible Party):
Istituto Clinico Humanitas

Study Description
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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, 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.

Condition or disease Intervention/treatment
Pancreatic Cancer Diagnostic Test: Liquid biopsy

Detailed Description:

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 Design
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Cases
Subjects affected by Pancreatic carcinoma (PC) confirmed by tissue biopsy
 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
 Diagnostic Test: Liquid biopsy
Detection and quantification of EMT-transcription factor mRNA levels in blood


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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
mRNA from whole blood

Eligibility Criteria
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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
Study Population

This is a prospective pathological and molecular study of screening for pancreatic cancer. The main objectives of the trial are:

  1. 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.
  2. To correlate the presence of molecular markers in the samples with the presence of pancreatic cancer or pre-cancerous lesions.
  3. 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.
Criteria

Inclusion Criteria:

  1. Males or females over 18 years of age capable of providing informed consent.
  2. Pancreatic carcinoma confirmed by tissue biopsy or colon mass, clinically consistent with cancer and eventually confirmed by pathology.
  3. Subject were enrolled following colon cancer screening via colonoscopy

Exclusion Criteria:

  1. Patients under the age of 18 years or over the age of 80 years.
  2. Patients with personal history of cancer, identification of large polyp or adenomatous pathology on previous or subsequent colonoscopy
  3. Patient with history of abdominal surgery within the past four months
  4. Patients unwilling to or unable to give informed consent.
  5. Patients with acute inflammatory diseases or under any emergency condition.
  6. Pregnant women.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Luigi AG Laghi, MD, PhD 02 8224 ext 4572 luigi.laghi@humanitas.it
Contact: Luana Greco, MD, MSci luana.greco@humanitasresearch.it

Locations
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Italy
Istituto Clinico humanitas Recruiting
Milan, Italy, 20089
Contact: Luigi Laghi, MD    +390282244572    luigi.laghi@humanitas.it   
Principal Investigator: Luigi Laghi, MD         
Sponsors and Collaborators
Istituto Clinico Humanitas
IRCCS San Raffaele
More Information
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Publications:

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Clinico Humanitas:
Epithelial to Mesenchymal Transition
EMT
PC
mRNA
 EMT-TF
Diagnosis
Biomarkers
Liquid biopsy
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases