Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-30 @ 10:56 AM
Study NCT ID:
NCT05170360
Status:
UNKNOWN
Last Update Posted:
2021-12-28
First Post:
2021-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Some Risk Factors Associated With Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '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'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-18', 'studyFirstSubmitDate': '2021-12-05', 'studyFirstSubmitQcDate': '2021-12-18', 'lastUpdatePostDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. association between some risk factors and colorectal cancer', 'timeFrame': 'baseline', 'description': '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'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': 'baseline', 'description': 'Surgically resected specimens will be collected; the samples will be used to determine the mutation in k-ras and BRAF genes by PCR\n\nRisk 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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '32767693', 'type': 'BACKGROUND', 'citation': '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': '31838757', 'type': 'BACKGROUND', 'citation': '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': '27276710', 'type': 'BACKGROUND', 'citation': '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': '20845292', 'type': 'BACKGROUND', 'citation': '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': '10958945', 'type': 'BACKGROUND', 'citation': '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': '32485528', 'type': 'BACKGROUND', 'citation': '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': '31280041', 'type': 'BACKGROUND', 'citation': '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': '24692581', 'type': 'BACKGROUND', 'citation': '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': '26965280', 'type': 'BACKGROUND', 'citation': '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': '33518157', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '1. Evaluation of some risk factors (e.g. smoking, heavy metal exposure, and organophosphorus exposure) on CRC.\n2. Estimation of KRAS and BRAF genes mutations associated with CRC.\n3. Association between different risk factors and gene mutations on different types of CRC.', 'detailedDescription': "* 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).\n* 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).\n* 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).\n* 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).\n* 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).\n* 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'the patient group is 50 patients who are recently diagnosed with CRC based on clinical and pathological examinations.\n\nTHE control group is 50 subjects who will be CRC-free, based on the clinical history and physical examination.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- 1. Patients who are recently diagnosed with CRC based on clinical and pathological examinations.\n\n2\\. Control subjects will be CRC-free, based on the clinical history and physical examination.\n\nExclusion Criteria:\n\n1 - 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)'}, 'identificationModule': {'nctId': 'NCT05170360', 'briefTitle': 'Evaluation of Some Risk Factors Associated With Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Evaluation of Some Risk Factors Associated With Colorectal Cancer and Their Correlation With KRAS and BRAF Genes Mutations', 'orgStudyIdInfo': {'id': 'colorectal cancer risk factors'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patient group', 'description': 'Patients who are recently diagnosed with CRC based on clinical and pathological examinations', 'interventionNames': ['Diagnostic Test: Assessment of smoking ,heavy metal, organophosphorus exposure and d) Mutational analysis of the KRAS and BRAF genes:']}, {'label': 'control group', 'description': 'Control subjects will be CRC-free, based on the clinical history and physical examination.', 'interventionNames': ['Diagnostic Test: Assessment of smoking ,heavy metal, organophosphorus exposure and d) Mutational analysis of the KRAS and BRAF genes:']}], 'interventions': [{'name': 'Assessment of smoking ,heavy metal, organophosphorus exposure and d) Mutational analysis of the KRAS and BRAF genes:', 'type': 'DIAGNOSTIC_TEST', 'description': '1. Assessment of smoking exposure:\n\n Serum cotinine will be measured by using serum cotinine ELISA kits\n2. Assessment of heavy metal exposure:\n\n Lead and cadmium will be measured using Graphite Tube Atomizer.\n3. Assessment of organophosphorus exposure:\n\n By measuring pseudocholinesterase level by spectrophotometer\n4. Mutational analysis of the KRAS and BRAF genes:\n\nthe tissue samples will be used to determine the mutation in k-ras and BRAF genes by RCR', 'armGroupLabels': ['control group', 'patient group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sarah A. Mohammed, Assistant lecturer', 'role': 'CONTACT', 'email': 'Sara_abdelsamee@yahoo.com', 'phone': '0201062031286'}, {'name': 'Hala M. Fathy, prof.DR', 'role': 'CONTACT', 'email': 'halamfk2015@gmail.com', 'phone': '01098038310'}], 'overallOfficials': [{'name': 'Hayam Z Thabet, prof.DR', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Heba A. Yassa, prof.DR', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer in Forensic Medicine and Clinical Toxicology Department', 'investigatorFullName': 'Sarah Abdelsamee Mohammed Ali', 'investigatorAffiliation': 'Assiut University'}}}}