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"High Levels of EMT-TFs for the Diagnosis of Colorectal Cancer (CRC)"

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ClinicalTrials.gov Identifier: NCT04323813
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : March 27, 2020
Sponsor:
Collaborators:
Cliniche Gavazzeni spa - Bergamo (BG)
Istituto Clinico Mater Domini - Castellanza (VA)
Humanitas Gradenigo - Torino
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 colorectal cancer (CRC) patients and healthy controls, to determine the presence of disease, its progression and risk of recurrence.

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

Detailed Description:

The investigators first provided evidence that human colorectal cancer (CRC) 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 CRC 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 mostly 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 mRNAs are significantly and steadily increased in the blood of CRC patients. These findings indicate that EMT players in the circulation change during different phases of CRC progression.

The present study is aimed at detecting and measuring messenger ribonucleic acid (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 possibly the risk of recurrence, even in patients who will be treated with adjuvant therapy on clinical ground.

Aim of this study is to depict the molecular profile of EMT transcription factor (EMT-TFs) variations in the blood of patients with early, intermediate or advanced CRC, with respect to disease progression and delivered treatments.

Primary endpoint: To determ the stage, the remission or the progression of a colorectal cancer in a colorectal 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 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 : 900 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: "High Levels of EMT-TFs for the Diagnosis of Colorectal Cancer (CRC)"
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Cases
CRC patients: primary, Stage I-IV (localized, node negative or node positive) colon carcinoma confirmed by tissue biopsy, and patients with advanced adenoma (including high-grade dysplasia, HGD).
 Diagnostic Test: Liquid biopsy
Detection and quantification of EMT-transcription factor mRNA levels in blood
Controls
Controls subjects as well as healthy clean colonoscopy subjects or with hyperplastic polyps, and healthy subjects with diminutive adenoma-low grade dysplasia (LGD) and with inflammatory bowel disease (IBD).
 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 CRC by EMT-TF mRNA levels in blood [ Time Frame: Analysis at day 0: at diagnosis or before surgery for CRC patients; before colonoscopy in controls ]
    To determine the stage, the remission or the progression of a colorectal cancer in a colorectal 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 CRC 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 CRC 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 multicenter, prospective cohort study of molecular screening for primary colon cancer. The main objectives of the trial are:

  1. To develop a specific and reproducible assay for the detection colorectal cancer based on blood RNA and to amplify cancer-specific molecular markers using RT-PCR.
  2. To correlate the presence of molecular markers in the samples with the presence of colon cancer or pre-cancerous lesions.
  3. 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. Primary, Stage I-IV [localized, node negative or node positive] colon carcinoma confirmed by tissue biopsy or colon mass, clinically consistent with cancer and eventually confirmed by pathology.
  3. Patients free from other neoplastic disease and related chemo / radio / adjuvant or neo-adjuvant therapies for at least 5 years, with documented complete remission.
  4. Controls subjects as well as healthy clean colonoscopy subjects or with hyperplastic polyps, and healthy subjects with low grade dysplasia (LGD) and high grade dysplasia (HGD) and with inflammatory bowel disease (IBD)

Exclusion Criteria:

  1. Patients under the age of 18 years or over the age of 80 years.
  2. Patients unwilling to or unable to give informed consent.
  3. Patients with a new metacrone tumor (post-operative for previous CRC resection within 5 years before study enrollment).
  4. Patients who are undergoing to "sandwich" surgery between two chemotherapeutic treatments
  5. Patients diagnosed with invasive cancer of other organs within 5 years before study enrollment .
  6. Patients with acute inflammatory diseases or under any emergency condition.
  7. 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): NCT04323813


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

Locations
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Italy
Istituto Clinico Humanitas Recruiting
Rozzano, Milano, Italy, 20089
Contact: Laghi AG Luigi, MD, PhD         
Sponsors and Collaborators
Istituto Clinico Humanitas
Cliniche Gavazzeni spa - Bergamo (BG)
Istituto Clinico Mater Domini - Castellanza (VA)
Humanitas Gradenigo - Torino
Investigators
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Principal Investigator: Luigi AG Laghi, MD, PhD Humanitas Clinical Institute
More Information
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Publications of Results:

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Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT04323813    
Other Study ID Numbers: EMT CRC 1.1
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 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
CRC
mRNA
 EMT-TF
Diagnosis
Biomarkers
Liquid biopsy
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases