Colorectal NeoplasmsNCT05170360
Evaluation of Some Risk Factors Associated With Colorectal Cancer
An observational study of Colorectal Neoplasms, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Assessment of smoking ,heavy metal, organophosphorus exposure and d) Mutational analysis of the KRAS and BRAF genes:
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Some Risk Factors Associated With Colorectal Cancer and Their Correlation With KRAS and BRAF Genes Mutations
- Evaluation of some risk factors (e.g. smoking, heavy metal exposure, and organophosphorus exposure) on CRC.
- Estimation of KRAS and BRAF genes mutations associated with CRC.
- Association between different risk factors and gene mutations on different types of CRC.
Read the 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).
- Conditions
- Colorectal Neoplasms
- Being tested
- Assessment of smoking ,heavy metal, organophosphorus exposure and d) Mutational analysis of the KRAS and BRAF genes:
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of smoking ,heavy metal, organophosphorus exposure and d) Mutational analysis of the KRAS and BRAF genes:Diagnostic test
- Assessment of smoking exposure: Serum cotinine will be measured by using serum cotinine ELISA kits
- Assessment of heavy metal exposure: Lead and cadmium will be measured using Graphite Tube Atomizer.
- Assessment of organophosphorus exposure: By measuring pseudocholinesterase level by spectrophotometer
- 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
| Study group | Role | What they receive |
|---|---|---|
| patient group | Patients who are recently diagnosed with CRC based on clinical and pathological examinations Receives: 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. Receives: Diagnostic Test: Assessment of smoking ,heavy metal, organophosphorus exposure and d) Mutational analysis of the KRAS and BRAF genes: |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study startDec 2021 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Abdelsamee Mohammed Ali, Assiut University
- Investigators
- Hayam Z Thabet, prof.DR, Study director, Assiut UniversityHeba A. Yassa, prof.DR, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170360
- Sponsor's protocol ID
- colorectal cancer risk factors
- Status last verified
- Dec 2021
- First submitted
- 5 Dec 2021
- Last updated
- 28 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32767693Forte 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.
PubMed 31838757Kudryavtseva 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.
PubMed 27276710Nanda 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.
PubMed 20845292Przybojewska 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.
PubMed 10958945Frisone 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.
PubMed 32485528Sjerps 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.
PubMed 31280041Walter 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.
PubMed 24692581Wu 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.
PubMed 26965280Zhou 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.
PubMed 33518157
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Some Risk Factors Associated With Colorectal Cancer and Their Correlation With KRAS and BRAF Genes Mutations
- ClinicalTrials.gov ID
- NCT05170360
- Acronym / sponsor ID
- colorectal cancer risk factors
- Conditions
- Colorectal Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 28 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Evaluation of some risk factors (e.g. smoking, heavy metal exposure, and organophosphorus exposure) on CRC.
- Estimation of KRAS and BRAF genes mutations associated with CRC.
- Association between different risk factors and gene mutations on different types of CRC.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient group | – | Diagnostic Test: Assessment of smoking ,heavy metal, organophosphorus exposure and d) Mutational analysis of the KRAS and BRAF genes:Patients who are recently diagnosed with CRC based on clinical and pathological examinations |
| control group | – | Diagnostic Test: Assessment of smoking ,heavy metal, organophosphorus exposure and d) Mutational analysis of the KRAS and BRAF genes:Control subjects will be CRC-free, based on the clinical history and physical examination. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | control group, patient group |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Background: PubMed 32767693Erratum: 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.
- Background: PubMed 31838757Forte 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.
- Background: PubMed 27276710Kudryavtseva 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.
- Background: PubMed 20845292Nanda 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.
- Background: PubMed 10958945Przybojewska 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.
- Background: PubMed 32485528Frisone 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.
- Background: PubMed 31280041Sjerps 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.
- Background: PubMed 24692581Walter 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.
- Background: PubMed 26965280Wu 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.
- Background: PubMed 33518157Zhou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hayam Z Thabet, prof.DR study director
Assiut University
Heba A. Yassa, prof.DR study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah A. Mohammed, Assistant lecturer (0201062031286, Sara_abdelsamee@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. association between some risk factors and colorectal cancer (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05170360, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021.