Status:
UNKNOWN
"High Levels of EMT-TFs for the Diagnosis of Colorectal Cancer (CRC)"
Lead Sponsor:
Istituto Clinico Humanitas
Collaborating Sponsors:
Cliniche Gavazzeni spa - Bergamo (BG)
Istituto Clinico Mater Domini - Castellanza (VA)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
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 ...
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 tr...
Eligibility Criteria
Inclusion
- Males or females over 18 years of age capable of providing informed consent.
- 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.
- Patients free from other neoplastic disease and related chemo / radio / adjuvant or neo-adjuvant therapies for at least 5 years, with documented complete remission.
- 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
- Patients under the age of 18 years or over the age of 80 years.
- Patients unwilling to or unable to give informed consent.
- Patients with a new metacrone tumor (post-operative for previous CRC resection within 5 years before study enrollment).
- Patients who are undergoing to "sandwich" surgery between two chemotherapeutic treatments
- Patients diagnosed with invasive cancer of other organs within 5 years before study enrollment .
- Patients with acute inflammatory diseases or under any emergency condition.
- Pregnant women.
Key Trial Info
Start Date :
September 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT04323813
Start Date
September 1 2017
End Date
September 1 2022
Last Update
March 27 2020
Active Locations (1)
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1
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089