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NCT Number: NCT06738225

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Diagnostic Test

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

Primary outcomes

  1. evaluation the diagnostic value of miRNAs as biomarkers of CRC by comparing its expression levels in CRC patients and normal individuals

    Time frame: baseline

    use the results of measurement of certain serum miRNAs in persons with CRC and non-CRC individuals.

Secondary outcomes

  1. assessment the correlation between miRNAs expression levels and clinicopathological features such as tumor stage, grade, and metastasis

    Time frame: baseline

    use the results of measurement of certain serum miRNAs in persons with CRC and non-CRC individuals.

  2. evaluation the sensitivity, specificity, and diagnostic accuracy of miRNAs as standalone biomarkers

    Time frame: baseline

    use the results of measurement of certain serum miRNAs in persons with CRC and non-CRC individuals.

Study contacts

Contact information is provided by the study sponsor or research team.

Bishoy Mahrous, MD

CONTACT

[email protected]

01271724587

Muhammad El-Masry

CONTACT

[email protected]

01212401707

Sponsors and collaborators

Lead sponsor

Bishoy Shehata

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 17, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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