- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06379035
Blastocystis and Cryptosporidium Infection in Colorectal Cancer Patients
April 18, 2024 updated by: Merna Hany Adly Ghaly, Assiut University
- Detect the prevelance of Blastocystis spp. and Cryptosporidium spp. among patients with colorectal cancer attending South Egypt Cancer Institute-Assiut University.
- Detect the effect of Blastocystis and Cryptosporidium infection on various cytokines level in CRC patients that may be involved in the tumor progression.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
54
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Merna Hany, Master
- Phone Number: 01227994945
- Email: mirnahany14497@aun.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
- Colorectal cancer confirmed patients by imaging techniques (CT or MRI) and histopathological biopsy by Colonoscopy.
- 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.
Description
Inclusion Criteria:
The persons selected for the study are those who are:
- Colorectal cancer confirmed patients by imaging techniques (CT or MRI) and histopathological biopsy by Colonoscopy.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Detect the prevelance of Blastocystis spp. and Cryptosporidium spp. among patients with colorectal cancer attending South Egypt Cancer Institute-Assiut University.
Time Frame: Baseline
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Detect the effect of Blastocystis and Cryptosporidium infection on various cytokines level in CRC patients that may be involved in the tumor progression.
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Salma Mohammed Abd-ElRahman, Prof.Dr, Assiut University
- Study Director: Rasha Abd-ElMonem Hassan, Prof.Dr, Assiut University
- Study Director: Yasser Mohamed Mokhtar, Assis.Prof.Dr, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 1, 2024
Primary Completion (Estimated)
November 1, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
April 18, 2024
First Submitted That Met QC Criteria
April 18, 2024
First Posted (Actual)
April 23, 2024
Study Record Updates
Last Update Posted (Actual)
April 23, 2024
Last Update Submitted That Met QC Criteria
April 18, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Disease Attributes
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Intestinal Diseases, Parasitic
- Parasitic Diseases
- Protozoan Infections, Animal
- Parasitic Diseases, Animal
- Coccidiosis
- Protozoan Infections
- Amebiasis
- Infections
- Communicable Diseases
- Colorectal Neoplasms
- Cryptosporidiosis
- Blastocystis Infections
Other Study ID Numbers
- Protozoa in CRC patients
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.