Evaluation of Some Risk Factors Associated With Colorectal Cancer

December 18, 2021 updated by: Sarah Abdelsamee Mohammed Ali, Assiut University

Evaluation of Some Risk Factors Associated With Colorectal Cancer and Their Correlation With KRAS and BRAF Genes Mutations

  1. Evaluation of some risk factors (e.g. smoking, heavy metal exposure, and organophosphorus exposure) on CRC.
  2. Estimation of KRAS and BRAF genes mutations associated with CRC.
  3. Association between different risk factors and gene mutations on different types of CRC.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  • Colorectal cancer (CRC) ranks as the third most common cancer globally and second in terms of mortality (Bray et al., 2018). CRC is the 7th commonest cancer in Egypt, representing 3.47% of male cancers and 3% of female cancers (Metwally et al.,2018).
  • Studies have provided that rising CRC rates are associated with increased alcohol use, physical inactivity, high intake of fat, red and processed meat, and processed foods; and low intake of fiber (Zhou and Rifkin, 2021).
  • Smoking is an established risk factor for colorectal adenomas as well as CRC incidence and mortality, which suggests that it may affect the prognosis of CRC patients as well (Walter et al., 2014).
  • Heavy metals are natural components of the earth's crust, which, if released into the environment, can persist for many years (Wu et al., 2016). The most toxic elements are arsenic, cadmium, chromium, copper, mercury, and lead with the majority of them being classified as certainly or probably carcinogenic (Forte et al., 2020).
  • Pesticides that are applied to farms can remain in the environment for longer than intended (Sjerps et al., 2019). Pesticides increase the risk of cancer through a variety of mechanisms including genotoxicity, epigenetic effects, hormonal action, and immunotoxicity (Lyons and Watterson, 2010).
  • Of the key genes of CRC, KRAS mutations are the most widely known, as they are mainly localized in codons 12 and 13, which were among the first linked to the pathogenesis of colon cancer (Kudryavtseva et al., 2016). BRAF is an oncogene located on chromosome 7 for which gain of function mutations in multiple solid tumors, such as colon cancer (Frisone et al., 2020).

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Contact

Study Contact Backup

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

the patient group is 50 patients who are recently diagnosed with CRC based on clinical and pathological examinations.

THE control group is 50 subjects who will be CRC-free, based on the clinical history and physical examination.

Description

Inclusion Criteria:

- 1. Patients who are recently diagnosed with CRC based on clinical and pathological examinations.

2. Control subjects will be CRC-free, based on the clinical history and physical examination.

Exclusion Criteria:

1 - Patient refuses to be enrolled in the study. 2. Subjects with cancer metastasized from other tissues to the colon. (colon is the site of metastasis)

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: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patient group
Patients who are recently diagnosed with CRC based on clinical and pathological examinations
Diagnostic test: Assessment of smoking ,heavy metal, organophosphorus exposure and d) Mutational analysis of the KRAS and BRAF genes:

  1. Assessment of smoking exposure:

    Serum cotinine will be measured by using serum cotinine ELISA kits

  2. Assessment of heavy metal exposure:

    Lead and cadmium will be measured using Graphite Tube Atomizer.

  3. Assessment of organophosphorus exposure:

    By measuring pseudocholinesterase level by spectrophotometer

  4. Mutational analysis of the KRAS and BRAF genes:

the tissue samples will be used to determine the mutation in k-ras and BRAF genes by RCR
control group
Control subjects will be CRC-free, based on the clinical history and physical examination.
Diagnostic test: Assessment of smoking ,heavy metal, organophosphorus exposure and d) Mutational analysis of the KRAS and BRAF genes:

  1. Assessment of smoking exposure:

    Serum cotinine will be measured by using serum cotinine ELISA kits

  2. Assessment of heavy metal exposure:

    Lead and cadmium will be measured using Graphite Tube Atomizer.

  3. Assessment of organophosphorus exposure:

    By measuring pseudocholinesterase level by spectrophotometer

  4. Mutational analysis of the KRAS and BRAF genes:

the tissue samples will be used to determine the mutation in k-ras and BRAF genes by RCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. association between some risk factors and colorectal cancer
Time Frame: baseline
association between smoking( by measuring serum cotinine ng/ml) , heavy metal (by measuring lead and cadmium in the blood μg/dLwill be measured using Graphite Tube Atomizer) , organophosphorus exposure (By measuring serum pseudocholinesterase level U/ml by spectrophotometer) and colorectal cancer incidience
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Estimation of KRAS and BRAF genes mutations associated with CRC. 3. Association between these risk factors and gene mutations on different types of CRC.
Time Frame: baseline

Surgically resected specimens will be collected; the samples will be used to determine the mutation in k-ras and BRAF genes by PCR

Risk factor smoking, heavy metal (lead and cadmium), organophosphorus exposure association between smoking( by measuring serum cotinine ng/ml), heavy metal (by measuring lead and cadmium in the blood μg/dLwill be measured using Graphite Tube Atomizer), organophosphorus exposure (By measuring serum pseudocholinesterase level U/ml by spectrophotometer), and colorectal cancer incidence
baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Hayam Z Thabet, prof.DR, Assiut University
  • Study Director: Heba A. Yassa, prof.DR, Assiut University

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 (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

December 5, 2021

First Submitted That Met QC Criteria

December 18, 2021

First Posted (Actual)

December 28, 2021

Study Record Updates

Last Update Posted (Actual)

December 28, 2021

Last Update Submitted That Met QC Criteria

December 18, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • colorectal cancer risk factors

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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