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Serum MicroRNAs as Diagnostic Biomarkers of Colorectal Cancer

NCT ID: NCT06738225

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-01

Study Completion Date

2027-05-01

Brief Summary

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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

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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.

Conditions

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MicroRNAs Colorectal Cancer miR-15b miR-21

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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cases

Persons has Colorectal cancer

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

Intervention Type DIAGNOSTIC_TEST

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

Control

Persons do not have Colorectal cancer

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bishoy Shehata

OTHER

Sponsor Role lead

Responsible Party

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Bishoy Shehata

Assistant lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Bishoy Mahrous, MD

Role: CONTACT

Phone: 01271724587

Email: [email protected]

Muhammad El-Masry

Role: CONTACT

Phone: 01212401707

Email: [email protected]

Other Identifiers

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MicroRNAs , colorectal cancer

Identifier Type: -

Identifier Source: org_study_id