Implication of Genetic Variations in Long Intergenic Non-coding RNA 00511 (LINC00511) in Colorectal Cancer

NCT06534242 | Completed

• 1 other identifier: RHDIRB2020110301REC-2022
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

As, there is a lack of information about the association between LINC00511 SNP(s) variants and CRC susceptibility, so this study was undertaken to address whether these SNPs would increase CRC risk or could predict its prognosis. The aim of this study was to investigate the association between LINC00511 SNPs (rs17780195 or rs9906859 and rs1558535) and CRC susceptibility and/or pathogenesis in addition to finding out the interaction between these SNPs and clinicopathological factors such as histopathological type, tumor size, lymph node metastasis and tumor grade.

Conditions

Colorectal Cancer

Keywords

LINC00511; SNPs; CRC

Outcome Measures

Primary Outcomes (2)

• Exploring whether LINC00511 SNP(s) variants influence CRC susceptibility by performing an observational study employing Egyptian CRC patients', evaluating the associations between LINC00511 SNPs (rs17780195 or rs9906859, and rs1558535) and CRC risk

  By using Taqman SNP genotyping assay

  One year

• Exploring if LINC00511 SNPs could predict CRC prognosis, with odds ratio (OR) and 95% confidence interval (CI) under credible genetic models.

  by statistical analysis

  3 months

Study Arms (2)

CRC cases

Inclusion is adult and confirmed pathological examination of newly diagnosed CRC of no specific type. Exclusion attributes that prevent a person from being included in the study were blood diseases, patients with HBV, schistosomiasis, HIV, alcohol intake, thyroid dysfunction, inflammatory diseases, diabetes mellitus, and cardiovascular disorders. Subjects receiving any chemotherapy or radiotherapy, or had undergone a GIT surgical operation, patients with blood disorder diseases, any cancer other than CRC, patients with neuronal diseases, respiratory diseases, uterine diseases, kidney diseases, cirrhosis of the liver, prolonged use of corticosteroids or sex hormones.

Controls

Apparently healthy, age and sex matched, 100 volunteers, not suffering from any disease or taking any medication. Control subjects with normal kidney functions and liver enzyme levels, absence of any clinical or laboratory evidence of CRC, were recruited during routine checkup examinations for themselves or their relatives or from the Chronic Diseases Screening National Presidential Program.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 200 CRC patients were recruited from Mansoura University Hospitals. After frequency matching (age ± 2 years), a total of 200 control subjects were randomly selected and recruited during routine checkup examinations for themselves or their relatives or from the Chronic Diseases Screening National Presidential Program.

You may qualify if:

• Adult and confirmed pathological examination of newly diagnosed CRC of no specific type.

You may not qualify if:

• Patients with HBV, schistosomiasis, HIV, alcohol intake, thyroid dysfunction, inflammatory diseases, diabetes mellitus, and cardiovascular disorders.
• Subjects receiving any chemotherapy or radiotherapy, or had undergone a GIT surgical operation, patients with blood disorder diseases, any cancer other than CRC, patients with neuronal diseases, respiratory diseases, uterine diseases, kidney diseases, cirrhosis of the liver, prolonged use of corticosteroids or sex hormones.

Sponsors & Collaborators

• Ain Shams University: lead
• Academy of Scientific Research and Technology, Egypt: collaborator

Study Sites (1)

Faculty of pharmacy, Ain Shams University, Advanced Biochemisrty Research Lab

Cairo, Egypt

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Nadia M. Hamdy, PhD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: January 20, 2022
• Primary Completion: February 15, 2023
• Study Completion: November 26, 2023
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

EG (1)