NCT04323813

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 900 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Liquid biopsy	Detection and quantification of EMT-transcription factor mRNA levels in blood

Timeline

• Start date: 2017-09-01
• Primary completion: 2021-09-01
• Completion: 2022-09-01
• First posted: 2020-03-27
• Last updated: 2020-03-27

Locations

1 site across 1 country: Italy