Clinical trial · Observational
"High Levels of EMT-TFs for the Diagnosis of Colorectal Cancer (CRC)"
NCT04323813CI-TRIAL-00044306unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liquid biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cases
- description
- 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).
- interventionNames
- Diagnostic Test: Liquid biopsy
- label
- Controls
- description
- 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).
- interventionNames
- Diagnostic Test: Liquid biopsy
Primary outcomes (1)
- measure
- Assessments of diagnosis of CRC by EMT-TF mRNA levels in blood
- timeFrame
- Analysis at day 0: at diagnosis or before surgery for CRC patients; before colonoscopy in controls
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTCelesti 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 23684708