MicroRNAsNCT06738225
Serum MicroRNAs as Diagnostic Biomarkers of Colorectal Cancer
An observational study of MicroRNAs and Colorectal Cancer, run by Bishoy Shehata.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- MicroRNAs, Colorectal Cancer, miR-15b
- What is being tested?
- certain serum MicroRNA biomarkers (miR-15b and miR-21)
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients attending assiut university hospital
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
evaluation the diagnostic value of certain MicroRNAs as biomarkers of Colorectal cancer by comparing its expression levels in Colorectal cancer patients and normal individuals.
Read the 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.
- Conditions
- MicroRNAs, Colorectal Cancer, miR-15b, miR-21
- Being tested
- certain serum MicroRNA biomarkers (miR-15b and miR-21)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
certain serum MicroRNA biomarkers (miR-15b and miR-21)Diagnostic test
miR-15b and miR-21 as diagnostic biomarkers of colorectal cancer
| Study group | Role | What they receive |
|---|---|---|
| cases | Persons has Colorectal cancer Receives: Diagnostic Test: certain serum MicroRNA biomarkers (miR-15b and miR-21) | |
| Control | Persons do not have Colorectal cancer Receives: Diagnostic Test: certain serum MicroRNA biomarkers (miR-15b and miR-21) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (2)
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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicroRNAsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bishoy Shehata
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bishoy Shehata, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738225
- Sponsor's protocol ID
- MicroRNAs , colorectal cancer
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum MicroRNAs as Diagnostic Biomarkers of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06738225
- Acronym / sponsor ID
- MicroRNAs , colorectal cancer
- Conditions
- MicroRNAs, Colorectal Cancer, miR-15b, miR-21
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bishoy ShehataUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | Diagnostic Test: certain serum MicroRNA biomarkers (miR-15b and miR-21)Persons has Colorectal cancer |
| Control | – | Diagnostic Test: certain serum MicroRNA biomarkers (miR-15b and miR-21)Persons do not have Colorectal cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending assiut university hospital
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| certain serum MicroRNA biomarkers (miR-15b and miR-21)miR-15b and miR-21 as diagnostic biomarkers of colorectal cancer | Diagnostic test | Control, cases |
Primary outcome
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.
2 secondary outcomes
assessment the correlation between miRNAs expression levels and clinicopathological features such as tumor stage, grade, and metastasis
Time frame: baseline
evaluation the sensitivity, specificity, and diagnostic accuracy of miRNAs as standalone biomarkers
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of MicroRNAs and Colorectal Cancer, run by Bishoy Shehata.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bishoy Mahrous, MD (01271724587, bishoy.shehta77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation the diagnostic value of miRNAs as biomarkers of CRC by comparing its expression levels in CRC patients and normal individuals (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.