Serum MicroRNAs as Diagnostic Biomarkers of Colorectal Cancer

evaluation the diagnostic value of certain MicroRNAs as biomarkers of Colorectal cancer by comparing its expression levels in Colorectal cancer patients and normal individuals.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; MicroRNAs; miR-15b; miR-21
• Intervention / Treatment: Diagnostic test: certain serum MicroRNA biomarkers (miR-15b and miR-21)

Detailed Description

Colorectal cancer (CRC) is the second commonest cause of cancer deaths and the third most common cancer worldwide. Five year survival of patients with stage 1 CRC is 92%, and decreases to 10% at stage 4 CRC. So, CRC diagnosing at an early stage is the most important factor influencing disease prognosis. Most CRC patients are diagnosed after being symptomatic, but studies show that once the symptoms are present it mostly signifies late-stage disease. colonoscopic screening of asymptomatic patients has been shown to pick up early-stage CRC. However, this is limited by cost issues and patient attitudes. Therefore, more efforts could be done to view to early diagnosis of CRC in asymptomatic patient. Biomarkers are molecules that can serve as signals of disease activity and pathological processes. CRC biomarkers can help in early diagnosis. MicroRNAs (miRNAs) are non-coding molecules that impact the expression of target genes in cell. Also, they exist in highly stable, cell free form in peripheral blood. They are detected by quantitative real time polymerase chain reaction (qRT-PCR). Data also shows that certain miRNAs are elevated in the plasma and tissues of CRC patients and decrease in plasma levels after operative treatment. There are over 2000 different miRNAs and they are estimated to regulate 30% of the human genome. miRNA dysregulation is also associated with multiple cancers. miRNAs seem to show significant promise with high sensitivity and specificity for CRC, but with limiting factors of limited data for high risk polyps and significant heterogeneity in test media and non-standardisation of test panels. Further research would be required to bridge these knowledge gaps. Interestingly, miR-15b and miR-21 appears to be the best diagnostic accuracy values for CRC.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Bishoy Mahrous, MD; Phone Number: 01271724587; Email: bishoy.shehta77@gmail.com
• Study Contact Backup: Name: Muhammad El-Masry; Phone Number: 01212401707; Email: muhammadelmasry@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients attending assiut university hospital

Description

Inclusion Criteria:

• Adults (age 18-75) diagnosed with primary CRC (histopathologically confirmed).
• CRC patients who have not received prior treatment (i.e., chemotherapy or radiation).
• Age-matched healthy controls without colorectal disease

Exclusion Criteria:

• Patients with secondary tumors or metastasis originating from non-colorectal sources.
• Patients with prior history of CRC.
• Patients who refuse to contribute in this study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cases; Persons has Colorectal cancer	Diagnostic test: certain serum MicroRNA biomarkers (miR-15b and miR-21); miR-15b and miR-21 as diagnostic biomarkers of colorectal cancer
Control; Persons do not have Colorectal cancer	Diagnostic test: certain serum MicroRNA biomarkers (miR-15b and miR-21); miR-15b and miR-21 as diagnostic biomarkers of colorectal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation the diagnostic value of miRNAs as biomarkers of CRC by comparing its expression levels in CRC patients and normal individuals	use the results of measurement of certain serum miRNAs in persons with CRC and non-CRC individuals.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment the correlation between miRNAs expression levels and clinicopathological features such as tumor stage, grade, and metastasis	use the results of measurement of certain serum miRNAs in persons with CRC and non-CRC individuals.	baseline
evaluation the sensitivity, specificity, and diagnostic accuracy of miRNAs as standalone biomarkers	use the results of measurement of certain serum miRNAs in persons with CRC and non-CRC individuals.	baseline

Collaborators and Investigators

• Sponsor: Bishoy Shehata

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: MicroRNAs , colorectal cancer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No