Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-02 @ 6:06 AM
Study NCT ID:
NCT06379035
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blastocystis and Cryptosporidium Infection in Colorectal Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016776', 'term': 'Blastocystis Infections'}, {'id': 'D003457', 'term': 'Cryptosporidiosis'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007411', 'term': 'Intestinal Diseases, Parasitic'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000562', 'term': 'Amebiasis'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011529', 'term': 'Protozoan Infections, Animal'}, {'id': 'D010273', 'term': 'Parasitic Diseases, Animal'}, {'id': 'D003048', 'term': 'Coccidiosis'}, {'id': 'D000820', 'term': 'Animal Diseases'}, {'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2024-04-18', 'studyFirstSubmitQcDate': '2024-04-18', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detect the prevelance of Blastocystis spp. and Cryptosporidium spp. among patients with colorectal cancer attending South Egypt Cancer Institute-Assiut University.', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Detect the effect of Blastocystis and Cryptosporidium infection on various cytokines level in CRC patients that may be involved in the tumor progression.', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blastocystis Infection', 'Cryptosporidium Infection', 'Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '30350310', 'type': 'BACKGROUND', 'citation': 'Ferlay J, Colombet M, Soerjomataram I, Mathers C, Parkin DM, Pineros M, Znaor A, Bray F. Estimating the global cancer incidence and mortality in 2018: GLOBOCAN sources and methods. Int J Cancer. 2019 Apr 15;144(8):1941-1953. doi: 10.1002/ijc.31937. Epub 2018 Dec 6.'}, {'pmid': '29672572', 'type': 'BACKGROUND', 'citation': 'Sulzyc-Bielicka V, Kolodziejczyk L, Jaczewska S, Bielicki D, Safranow K, Bielicki P, Kladny J, Rogowski W. Colorectal cancer and Cryptosporidium spp. infection. PLoS One. 2018 Apr 19;13(4):e0195834. doi: 10.1371/journal.pone.0195834. eCollection 2018.'}, {'pmid': '22278727', 'type': 'BACKGROUND', 'citation': 'Chan KH, Chandramathi S, Suresh K, Chua KH, Kuppusamy UR. Effects of symptomatic and asymptomatic isolates of Blastocystis hominis on colorectal cancer cell line, HCT116. Parasitol Res. 2012 Jun;110(6):2475-80. doi: 10.1007/s00436-011-2788-3. Epub 2012 Jan 26.'}, {'pmid': '35067864', 'type': 'BACKGROUND', 'citation': 'Ali SH, Ismail MAM, El-Badry AA, Abu-Sarea EY, Dewidar AM, Hamdy DA. An Association Between Blastocystis Subtypes and Colorectal Cancer Patients: A Significant Different Profile from Non-cancer Individuals. Acta Parasitol. 2022 Jun;67(2):752-763. doi: 10.1007/s11686-021-00508-y. Epub 2022 Jan 24.'}, {'pmid': '23933809', 'type': 'BACKGROUND', 'citation': 'Kumarasamy V, Kuppusamy UR, Samudi C, Kumar S. Blastocystis sp. subtype 3 triggers higher proliferation of human colorectal cancer cells, HCT116. Parasitol Res. 2013 Oct;112(10):3551-5. doi: 10.1007/s00436-013-3538-5. Epub 2013 Aug 10.'}, {'pmid': '33853659', 'type': 'BACKGROUND', 'citation': 'Sulzyc-Bielicka V, Kolodziejczyk L, Adamska M, Skotarczak B, Jaczewska S, Safranow K, Bielicki P, Kladny J, Bielicki D. Colorectal cancer and Blastocystis sp. infection. Parasit Vectors. 2021 Apr 14;14(1):200. doi: 10.1186/s13071-021-04681-x.'}, {'pmid': '23291034', 'type': 'BACKGROUND', 'citation': 'Abdou AG, Harba NM, Afifi AF, Elnaidany NF. Assessment of Cryptosporidium parvum infection in immunocompetent and immunocompromised mice and its role in triggering intestinal dysplasia. Int J Infect Dis. 2013 Aug;17(8):e593-600. doi: 10.1016/j.ijid.2012.11.023. Epub 2013 Jan 3.'}, {'pmid': '36853318', 'type': 'BACKGROUND', 'citation': 'Abd El-Latif NF, Kandil NS, Shamseya M, Elwany YN, Ibrahim HS. Role of Cryptosporidium spp in Development of Colorectal Cancer. Asian Pac J Cancer Prev. 2023 Feb 1;24(2):667-674. doi: 10.31557/APJCP.2023.24.2.667.'}, {'pmid': '35321272', 'type': 'BACKGROUND', 'citation': 'Kumarasamy V, Atroosh WM, Anbazhagan D, Abdalla MMI, Azzani M. Association of Blastocystis hominis with colorectal cancer: A systematic review of in vitro and in vivo evidences. World J Gastrointest Oncol. 2022 Mar 15;14(3):734-745. doi: 10.4251/wjgo.v14.i3.734.'}, {'pmid': '29973261', 'type': 'BACKGROUND', 'citation': 'Greige S, El Safadi D, Becu N, Gantois N, Pereira B, Chabe M, Benamrouz-Vanneste S, Certad G, El Hage R, Chemaly M, Hamze M, Viscogliosi E. Prevalence and subtype distribution of Blastocystis sp. isolates from poultry in Lebanon and evidence of zoonotic potential. Parasit Vectors. 2018 Jul 4;11(1):389. doi: 10.1186/s13071-018-2975-5.'}]}, 'descriptionModule': {'briefSummary': '1. Detect the prevelance of Blastocystis spp. and Cryptosporidium spp. among patients with colorectal cancer attending South Egypt Cancer Institute-Assiut University.\n2. Detect the effect of Blastocystis and Cryptosporidium infection on various cytokines level in CRC patients that may be involved in the tumor progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Colorectal cancer confirmed patients by imaging techniques (CT or MRI) and histopathological biopsy by Colonoscopy.\n2. Cooperative individuals attending South Egypt Cancer Institute - Assiut University of all ages and both sexes with confirmed diagnosis of CRC who agreed to be engaged in the study and were able to provide adequate samples.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The persons selected for the study are those who are:\n\n 1. Colorectal cancer confirmed patients by imaging techniques (CT or MRI) and histopathological biopsy by Colonoscopy.\n 2. Cooperative individuals attending South Egypt Cancer Institute - Assiut University of all ages and both sexes with confirmed diagnosis of CRC who agreed to be engaged in the study and were able to provide adequate samples.\n\nCRC Patients will be divided into 4 groups:\n\nGroup 1: CRC patients without Blastocystis or Cryptosporidium infection. Group 2 : CRC patients with Blastocystis infection. Group 3 : CRC patients with Cryptosporidium infection. Group 4 : CRC patients with both Blastocystis and Cryptosporidium infection.\n\nExclusion Criteria:\n\n* Patients having any type of tumors other than CRC. Patients taking anti-parasitic medications 2 weeks before sample collection.'}, 'identificationModule': {'nctId': 'NCT06379035', 'briefTitle': 'Blastocystis and Cryptosporidium Infection in Colorectal Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Blastocystis and Cryptosporidium Infection in Colorectal Cancer Patients', 'orgStudyIdInfo': {'id': 'Protozoa in CRC patients'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ELISA / PCR', 'type': 'DIAGNOSTIC_TEST', 'description': 'Multiplex PCR for confirmation of diagnosis of Blastocystis and Cryptosporidium infection.\n\nEnzyme linked immunosorbent assay (Elisa) for detection of :\n\nDifferent cytokines level in Colorectal cancer patients that may be involved in the tumor progression due to Blastocystis and Cryptosporidium infection.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Merna Hany, Master', 'role': 'CONTACT', 'email': 'mirnahany14497@aun.edu.eg', 'phone': '01227994945'}], 'overallOfficials': [{'name': 'Salma Mohammed Abd-ElRahman, Prof.Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Rasha Abd-ElMonem Hassan, Prof.Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Yasser Mohamed Mokhtar, Assis.Prof.Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Merna Hany Adly', 'investigatorFullName': 'Merna Hany Adly Ghaly', 'investigatorAffiliation': 'Assiut University'}}}}