Evaluation of Some Risk Factors Associated With Colorectal Cancer

NCT05170360 | Unknown

• 1 other identifier: colorectal cancer risk factors
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 1. association between some risk factors and colorectal cancer

  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 Outcomes (1)

• 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.

  baseline

Study Arms (2)

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:

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:

Interventions

Assessment of smoking ,heavy metal, organophosphorus exposure and d) Mutational analysis of the KRAS and BRAF genes: DIAGNOSTIC_TEST

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; patient group

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 1. Patients who are recently diagnosed with CRC based on clinical and pathological examinations.
• \. Control subjects will be CRC-free, based on the clinical history and physical examination.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assiut University: lead

Related Publications (10)

• Erratum: Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2020 Jul;70(4):313. doi: 10.3322/caac.21609. Epub 2020 Apr 6. No abstract available.

  PMID: 32767693 BACKGROUND

• Forte IM, Indovina P, Costa A, Iannuzzi CA, Costanzo L, Marfella A, Montagnaro S, Botti G, Bucci E, Giordano A. Blood screening for heavy metals and organic pollutants in cancer patients exposed to toxic waste in southern Italy: A pilot study. J Cell Physiol. 2020 Jun;235(6):5213-5222. doi: 10.1002/jcp.29399. Epub 2019 Dec 15.

  PMID: 31838757 BACKGROUND

• Kudryavtseva AV, Lipatova AV, Zaretsky AR, Moskalev AA, Fedorova MS, Rasskazova AS, Shibukhova GA, Snezhkina AV, Kaprin AD, Alekseev BY, Dmitriev AA, Krasnov GS. Important molecular genetic markers of colorectal cancer. Oncotarget. 2016 Aug 16;7(33):53959-53983. doi: 10.18632/oncotarget.9796.

  PMID: 27276710 BACKGROUND

• Nanda MS, Sameer AS, Syeed N, Shah ZA, Murtaza I, Siddiqi MA, Ali A. Genetic aberrations of the K-ras proto-oncogene in bladder cancer in Kashmiri population. Urol J. 2010 Summer;7(3):168-73.

  PMID: 20845292 BACKGROUND

• Przybojewska B, Jagiello A, Jalmuzna P. H-RAS, K-RAS, and N-RAS gene activation in human bladder cancers. Cancer Genet Cytogenet. 2000 Aug;121(1):73-7. doi: 10.1016/s0165-4608(00)00223-5.

  PMID: 10958945 BACKGROUND

• Frisone D, Friedlaender A, Malapelle U, Banna G, Addeo A. A BRAF new world. Crit Rev Oncol Hematol. 2020 Aug;152:103008. doi: 10.1016/j.critrevonc.2020.103008. Epub 2020 May 26.

  PMID: 32485528 BACKGROUND

• Sjerps RMA, Kooij PJF, van Loon A, Van Wezel AP. Occurrence of pesticides in Dutch drinking water sources. Chemosphere. 2019 Nov;235:510-518. doi: 10.1016/j.chemosphere.2019.06.207. Epub 2019 Jun 27.

  PMID: 31280041 BACKGROUND

• Walter V, Jansen L, Hoffmeister M, Brenner H. Smoking and survival of colorectal cancer patients: systematic review and meta-analysis. Ann Oncol. 2014 Aug;25(8):1517-25. doi: 10.1093/annonc/mdu040. Epub 2014 Mar 31.

  PMID: 24692581 BACKGROUND

• Wu X, Cobbina SJ, Mao G, Xu H, Zhang Z, Yang L. A review of toxicity and mechanisms of individual and mixtures of heavy metals in the environment. Environ Sci Pollut Res Int. 2016 May;23(9):8244-59. doi: 10.1007/s11356-016-6333-x. Epub 2016 Mar 11.

  PMID: 26965280 BACKGROUND

• Zhou E, Rifkin S. Colorectal Cancer and Diet: Risk Versus Prevention, Is Diet an Intervention? Gastroenterol Clin North Am. 2021 Mar;50(1):101-111. doi: 10.1016/j.gtc.2020.10.012.

  PMID: 33518157 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The DNA will be extracted from the primary tumor tissue and adjacent noncancerous tissues using the DNA extraction kit (proteinase K and phenol extraction) and then will be stored at 4 °C, for examining the mutations in the K-ras gene and BRAF

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

• Hayam Z Thabet, prof.DR

  Assiut University

  STUDY DIRECTOR

• Heba A. Yassa, prof.DR

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Sarah A. Mohammed, Assistant lecturer

CONTACT

0201062031286; Sara_abdelsamee@yahoo.com

Hala M. Fathy, prof.DR

CONTACT

01098038310; halamfk2015@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer in Forensic Medicine and Clinical Toxicology Department

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: December 28, 2021
• Study Start: December 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 28, 2021

Record last verified: 2021-12