Clinical trial NCT06379035: Blastocystis and Cryptosporidium Infection in Colorectal Cancer Patients
Official title: Blastocystis and Cryptosporidium Infection in Colorectal Cancer Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Blastocystis Infection
Cryptosporidium Infection
Colorectal Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Colorectal cancer confirmed patients by imaging techniques (CT or MRI) and histopathological biopsy by Colonoscopy.
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.

Brief summary: 1. Detect the prevelance of Blastocystis spp. and Cryptosporidium spp. among patients with colorectal cancer attending South Egypt Cancer Institute-Assiut University.
2. Detect the effect of Blastocystis and Cryptosporidium infection on various cytokines level in CRC patients that may be involved in the tumor progression.


Eligibility criteria: Inclusion Criteria:

* The persons selected for the study are those who are:

  1. Colorectal cancer confirmed patients by imaging techniques (CT or MRI) and histopathological biopsy by Colonoscopy.
  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.

CRC Patients will be divided into 4 groups:

Group 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.

Exclusion Criteria:

* Patients having any type of tumors other than CRC. Patients taking anti-parasitic medications 2 weeks before sample collection.

Primary outcomes:
measure: Detect the prevelance of Blastocystis spp. and Cryptosporidium spp. among patients with colorectal cancer attending South Egypt Cancer Institute-Assiut University.
timeFrame: Baseline
Secondary outcomes:
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
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
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
References:
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.
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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.
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.
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.
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.