Association of Autophagy-related Genes ,LncRNA and SNPs With Colorectal Cancer in Egyptian Population

April 27, 2025 updated by: Esraa Hassan,MD
  1. Determination of expression level of HOTTIP and EIF4EBP1(Eukaryotic translation initiation factor 4E-binding protein 1) .
  2. Investigation of the SNP HOTTIP rs1859168 and it's association with CRC susceptibility.
  3. Correlation of the expression of these genes with various stages of CRC to determine the prognostic value of each of them.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Colorectal cancer (CRC) is a common digestive tract tumor 1.It is the third leading cause of death in the world. Overall 5-year survival rate is less than 40%, and the occurrence is rising 2. However, the prognosis and therapy have not been significantly improved. Therefore, a proper selection of patients for aggressive treatment is necessary, new therapeutic and prognostic strategies are urgently needed 3.

Autophagy is a pathway for self-digestion, in which unwanted cytoplasmic components are recycled 4.In normal conditions, autophagy is essential for cellular homeostasis 5. Autophagy has dual roles in cancer cells, stimulation or suppression , with effects on progression and oncogenesis 6.Recent research established that autophagy is important target for controlling cancer depending on stage and type of tumor 7.Diverse molecular mechanisms contribute to cancer cells resistance to treatment 8.Among these mechanisms , autophagy appears to be critical 9.

EIF4EBP1 (Eukaryotic translation initiation factor 4E-binding protein 1) is encoded by EIF4EBP1 gene.It acts as an effector in mTOR (mammilian target of rapamycin) pathway which on activation ,EIF4EBP1 is phosphorylated promoting cell proliferation 10. Studies have suggested that EIF4EBP1 promotes carcinogenesis as in hepatocellular carcinoma .However, its role in CRC have not been elucidated 10.

Long non-coding RNAs (lncRNAs) are group of RNA , 200 nucleotides in length 11,. Expression of lncRNAs has been discovered in multiple tumors, acting as oncogenes. 'HOXA(hydrogenase transcriptional regulatory protein) transcript at the distal tip' (HOTTIP) has received attention lately.It is up-regulated in CRC tissue, regulating genes via epigenetic modification. Therefore, it might be a candidate for cancerization and therapy of CRC 12.

Expression of lncRNAs could be affected by single nucleotide polymorphisms (SNPs), the most common genetic variation in human genomes13. rs1859168 was reported as a potential functional polymorphism on HOTTIP that alters its expression level 14.. Also, it was recently reported that HOTTIP enhances interleukin 6 expression, which potentiates immune escape of cancer cells 15.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Healthy controls ( n = 30) matched as regarding age and sex as much as possible with cases.

-Colorectal cancer patients( n = 30 ) from stage I-III with the following criteria:-

Description

Inclusion Criteria:

  • No sex predilection.
  • Age (25-65 yr).
  • Colorectal carcinoma confirmed by histopathological examination

Exclusion Criteria:

  • -patients who received any treatment.
  • Cases with other organ cancers.
  • History of chemotherapy and radiotherapy.
  • Systemic diseases such as renal failure, diabetes mellitus, and hypertension.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
colorectal cancer patients

Colorectal cancer patients( n = 30 ) from stage I-III with the following criteria:-

a. Inclusion criteria:

  • No sex predilection.
  • Age (25-65 yr).
  • Colorectal carcinoma confirmed by histopathological examination
Diagnostic test: PBMCs and Tissue expression of HOTTIP ,EIF4EBP1 and serum SNP HOTTIP rs1859168
5 ml fresh blood sample, normal and CRC tissue
Healthy controls ( n = 30)
matched as regarding age and sex as much as possible with cases.
Diagnostic test: PBMCs and Tissue expression of HOTTIP ,EIF4EBP1 and serum SNP HOTTIP rs1859168
5 ml fresh blood sample, normal and CRC tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HOTTIP gene expression
Time Frame: 2 years
Estimation of expression level of HOTTIP in peripheral blood mononuclear cells and tissue aiming to use as possible less invasive prognostic markers for colorectal cancer.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EIF4EBP
Time Frame: 2 years
Estimation of expression level of EIF4EBP in peripheral blood mononuclear cells and tissue
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Esraa Hassan,MD

Collaborators

South Egypt Cancer Institute

Investigators

  • Principal Investigator: Esraa H Mohamed, Master, Assistant lecturer of Medical Microbiology and Immunology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2022

Primary Completion (Actual)

May 20, 2023

Study Completion (Actual)

September 20, 2024

Study Registration Dates

First Submitted

January 24, 2021

First Submitted That Met QC Criteria

January 27, 2021

First Posted (Actual)

January 29, 2021

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 27, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Esraa Hassan MD Protocol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

all researchers will have access to individual patient data with preserving confidentiality

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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