Blastocystis InfectionNCT06379035
Blastocystis and Cryptosporidium Infection in Colorectal Cancer Patients
An observational study of Blastocystis Infection and Cryptosporidium Infection, run by Assiut University.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blastocystis Infection, Cryptosporidium Infection, Colorectal Cancer
- What is being tested?
- ELISA / PCR
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients having any type of tumors other than CRC. Patients taking anti-parasitic medications 2 weeks before sample collection.
Trial locations and contacts
No sites are listed yet.
About this study
- 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.
- Being tested
- ELISA / PCR
- Medical subject headings
- Blastocystis Infections, Cryptosporidiosis, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISA / PCRDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect the prevelance of Blastocystis spp. and Cryptosporidium spp. among patients with colorectal cancer attending South Egypt Cancer Institute-Assiut University.
Measured: Baseline
Secondary outcomes (1)
Detect the effect of Blastocystis and Cryptosporidium infection on various cytokines level in CRC patients that may be involved in the tumor progression.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Blastocystis InfectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merna Hany Adly Ghaly, Assiut University
- Investigators
- Salma Mohammed Abd-ElRahman, Prof.Dr, Study director, Assiut UniversityRasha Abd-ElMonem Hassan, Prof.Dr, Study director, Assiut UniversityYasser Mohamed Mokhtar, Assis.Prof.Dr, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379035
- Sponsor's protocol ID
- Protozoa in CRC patients
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 30350310Sulzyc-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.
PubMed 29672572Chan 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.
PubMed 22278727Ali 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.
PubMed 35067864Kumarasamy 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.
PubMed 23933809Sulzyc-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.
PubMed 33853659Abdou 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.
PubMed 23291034Abd 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.
PubMed 36853318Kumarasamy 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.
PubMed 35321272Greige 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.
PubMed 29973261
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blastocystis and Cryptosporidium Infection in Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT06379035
- Acronym / sponsor ID
- Protozoa in CRC patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- The persons selected for the study are those who are:
- 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.
Key exclusion criteria (1 listed)
- Patients having any type of tumors other than CRC. Patients taking anti-parasitic medications 2 weeks before sample collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISA / PCRMultiplex 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. | Diagnostic test | – |
Primary outcome
Detect the prevelance of Blastocystis spp. and Cryptosporidium spp. among patients with colorectal cancer attending South Egypt Cancer Institute-Assiut University.
Time frame: Baseline
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Background: PubMed 30350310Ferlay 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.
- Background: PubMed 29672572Sulzyc-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.
- Background: PubMed 22278727Chan 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.
- Background: PubMed 35067864Ali 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.
- Background: PubMed 23933809Kumarasamy 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.
- Background: PubMed 33853659Sulzyc-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.
- Background: PubMed 23291034Abdou 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.
- Background: PubMed 36853318Abd 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.
- Background: PubMed 35321272Kumarasamy 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.
- Background: PubMed 29973261Greige 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salma Mohammed Abd-ElRahman, Prof.Dr study director
Assiut University
Rasha Abd-ElMonem Hassan, Prof.Dr study director
Assiut University
Yasser Mohamed Mokhtar, Assis.Prof.Dr study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Blastocystis Infection and Cryptosporidium Infection, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merna Hany, Master (01227994945, mirnahany14497@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect the prevelance of Blastocystis spp. and Cryptosporidium spp. among patients with colorectal cancer attending South Egypt Cancer Institute-Assiut University. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06379035, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.