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Serum MicroRNAs as Diagnostic Biomarkers of Colorectal Cancer

Serum MicroRNAs as Diagnostic Biomarkers of Colorectal Cancer

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06738225
Enrollment
80
Registered
2024-12-17
Start date
2025-03-01
Completion date
2027-05-01
Last updated
2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, MicroRNAs, miR-15b, miR-21

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTcertain serum MicroRNA biomarkers (miR-15b and miR-21)

miR-15b and miR-21 as diagnostic biomarkers of colorectal cancer

Sponsors

Bishoy Shehata
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
evaluation the diagnostic value of miRNAs as biomarkers of CRC by comparing its expression levels in CRC patients and normal individualsbaselineuse the results of measurement of certain serum miRNAs in persons with CRC and non-CRC individuals.

Secondary

MeasureTime frameDescription
assessment the correlation between miRNAs expression levels and clinicopathological features such as tumor stage, grade, and metastasisbaselineuse the results of measurement of certain serum miRNAs in persons with CRC and non-CRC individuals.
evaluation the sensitivity, specificity, and diagnostic accuracy of miRNAs as standalone biomarkersbaselineuse the results of measurement of certain serum miRNAs in persons with CRC and non-CRC individuals.

Contacts

Primary ContactBishoy Mahrous, MD
bishoy.shehta77@gmail.com01271724587
Backup ContactMuhammad El-Masry
muhammadelmasry@aun.edu.eg01212401707

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026