NCT06738225

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Mar 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Mar 2025May 2027

First Submitted

Initial submission to the registry

December 12, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

December 12, 2024

Last Update Submit

December 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    baseline

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

    baseline

Study Arms (2)

cases

Persons has Colorectal cancer

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

Control

Persons do not have Colorectal cancer

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

Interventions

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

Controlcases

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients attending assiut university hospital

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Bishoy Mahrous, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

December 12, 2024

First Posted

December 17, 2024

Study Start

March 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share