"High Levels of EMT-TFs for the Diagnosis of Colorectal Cancer (CRC)"
1 other identifier
observational
900
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 19, 2019
CompletedFirst Posted
Study publicly available on registry
March 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedMarch 27, 2020
March 1, 2020
4 years
December 19, 2019
March 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessments of diagnosis of CRC by EMT-TF mRNA levels in blood
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.
Analysis at day 0: at diagnosis or before surgery for CRC patients; before colonoscopy in controls
Secondary Outcomes (1)
Prediction of prognosis of CRC by EMT-TF mRNA levels in blood
Analysis at least: 7-15 days from surgery (T1), 30 days (T2) from surgery, 6 months (T3) from surgery, 1 year (T4) from surgery
Study Arms (2)
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).
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).
Interventions
Detection and quantification of EMT-transcription factor mRNA levels in blood
Eligibility Criteria
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.
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Istituto Clinico Humanitaslead
- Cliniche Gavazzeni spa - Bergamo (BG)collaborator
- Istituto Clinico Mater Domini - Castellanza (VA)collaborator
- Humanitas Gradenigo - Torinocollaborator
Study Sites (1)
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
Related Publications (1)
Celesti G, Di Caro G, Bianchi P, Grizzi F, Basso G, Marchesi F, Doni A, Marra G, Roncalli M, Mantovani A, Malesci A, Laghi L. Presence of Twist1-positive neoplastic cells in the stroma of chromosome-unstable colorectal tumors. Gastroenterology. 2013 Sep;145(3):647-57.e15. doi: 10.1053/j.gastro.2013.05.011. Epub 2013 May 15.
PMID: 23684708RESULT
Biospecimen
mRNA from whole blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luigi AG Laghi, MD, PhD
Humanitas Clinical Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2019
First Posted
March 27, 2020
Study Start
September 1, 2017
Primary Completion
September 1, 2021
Study Completion
September 1, 2022
Last Updated
March 27, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share
Data patent covered. No. Patent: EP13197367.9 - December 16, 2013