- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05850884
Evaluation of Intestinal Parasites in Patients With Intestinal Cancer in Sohag, Egypt.
November 24, 2023 updated by: Nagwa Ibrahim Selim, Sohag University
This study aims to evaluate the intestinal parasitic infections in patients with intestinal cancer in comparison to non-cancer individuals
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Intestinal parasitic infections continue to be characterized as a significant cause of morbidity worldwide, and according to World Health Organization (WHO) statistics, more than a quarter of the world's population, mostly in developing countries, are infected Acquisition of infection, clinical severity, and outcome of a parasitic disease depend on innate and acquired host immunity as well as on the parasite's response against the host when the infection is established Chronic infections and inflammation along with unhealthy diet, stressful lifestyle, cell damage, constant exposure to radiation, and harmful chemicals are risk factors for the development of cancers As infectious factors, the Blastocystis hominis and Cryptosporidium spp.
are opportunistic protozoa isolated from the human host gastrointestinal tract, These prevalent enteric parasites may cause serious challenges in people undergoing colorectal cancer treatment (chemotherapy)
Study Type
Observational
Enrollment (Estimated)
100
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: nagwa i seleem, dominstrator
- Phone Number: 002 01060289117
- Email: nagwaibrahim@med.sohag.edu.eg
Study Locations
-
-
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Sohag, Egypt
- Recruiting
- Sohag University
-
Contact:
- nagwa i seleem, demonstrator
- Phone Number: 002 01060289117
- Email: nagwaibrahim@med.sohag.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
N/A
Sampling Method
Probability Sample
Study Population
Case-control study
Description
Inclusion Criteria:
- intestinal cancer patients (colorectal cancer, intestinal lymphoma, gastrointestinal stromal tumors, and other malignant variants)
Exclusion Criteria:
- patient took antibiotics within the previous four weeks and anti-parasitic drugs within the previous two weeks
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
group A
• One hundred stool samples will be collected from patients with intestinal cancer admitted to Sohag Hospital.
|
Each collected sample will be divided into three parts; 1st part will be examined freshly without preservatives by macroscopic and microscopic examination, the 2nd part will be preserved for concentration techniques, staining, and microscopic examination and the 3rd part will be cultivated for Strongyloides stercoralis diagnosis
|
group B
one hundred stool samples will be collected from the control group of patients who attended outpatient clinics
|
Each collected sample will be divided into three parts; 1st part will be examined freshly without preservatives by macroscopic and microscopic examination, the 2nd part will be preserved for concentration techniques, staining, and microscopic examination and the 3rd part will be cultivated for Strongyloides stercoralis diagnosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
evaluate the intestinal parasitic infections in patients with intestinal cancer in comparison to non-cancer individuals
Time Frame: 12 months
|
• Each collected sample will be divided into three parts; 1st part will be examined freshly without preservatives by macroscopic and microscopic examination, the 2nd part will be preserved for concentration techniques, staining, and microscopic examination and the 3rd part will be cultivated for Strongyloides stercoralis diagnosis
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: nada a elnady, professor, Sohag University
- Study Chair: emad e nabil, ass prof, Sohag University
- Study Chair: manal r gaballah, lecturer, Sohag University
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 30, 2023
Primary Completion (Estimated)
April 30, 2024
Study Completion (Estimated)
May 30, 2024
Study Registration Dates
First Submitted
April 30, 2023
First Submitted That Met QC Criteria
April 30, 2023
First Posted (Actual)
May 9, 2023
Study Record Updates
Last Update Posted (Actual)
November 27, 2023
Last Update Submitted That Met QC Criteria
November 24, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-23-04-24MS_
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.
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