Blastocystis and Cryptosporidium Infection in Colorectal Cancer Patients

Colorectal Cancer Clinical Trial

Official title:

Blastocystis and Cryptosporidium Infection in Colorectal Cancer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06379035
• Other study ID #: Protozoa in CRC patients
• Status: Not yet recruiting
• Start date: November 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Assiut University
• Contact: Merna Hany, Master
• Phone: 01227994945
• Email: mirnahany14497[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: December 31, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Communicable Diseases
• Cryptosporidiosis
• Infections

Intervention

Diagnostic Test:
• ELISA / PCR
Multiplex PCR for confirmation of diagnosis of Blastocystis and Cryptosporidium infection. Enzyme linked immunosorbent assay (Elisa) for detection of : Different cytokines level in Colorectal cancer patients that may be involved in the tumor progression due to Blastocystis and Cryptosporidium infection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detect the prevelance of Blastocystis spp. and Cryptosporidium spp. among patients with colorectal cancer attending South Egypt Cancer Institute-Assiut University.		Baseline
Secondary	Detect the effect of Blastocystis and Cryptosporidium infection on various cytokines level in CRC patients that may be involved in the tumor progression.		Baseline