Intestinal Parasites in Patients With Intestinal CancerNCT05850884
Evaluation of Intestinal Parasites in Patients With Intestinal Cancer in Sohag, Egypt.
An observational study of Intestinal Parasites in Patients With Intestinal Cancer, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to evaluate the intestinal parasitic infections in patients with intestinal cancer in comparison to non-cancer individuals Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Intestinal Parasites in Patients With Intestinal Cancer
- What is being tested?
- stool examination
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2023to 30 May 2024
- How long will I take part?
- 12 Months
- 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 2 years and older
- All sexes
- Child, Adult, Older adult
Study population: Case-control study
Who may be able to join
- intestinal cancer patients (colorectal cancer, intestinal lymphoma, gastrointestinal stromal tumors, and other malignant variants)
Who cannot join
- patient took antibiotics within the previous four weeks and anti-parasitic drugs within the previous two weeks
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag
nagwa i seleem, demonstrator, 01060289117 ext. 002, nagwaibrahim@med.sohag.edu.eg
About this study
This study aims to evaluate the intestinal parasitic infections in patients with intestinal cancer in comparison to non-cancer individuals
Read the 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)
- Being tested
- stool examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stool examinationDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| group A | • One hundred stool samples will be collected from patients with intestinal cancer admitted to Sohag Hospital. Receives: Diagnostic Test: stool examination | |
| group B | one hundred stool samples will be collected from the control group of patients who attended outpatient clinics Receives: Diagnostic Test: stool examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the intestinal parasitic infections in patients with intestinal cancer in comparison to non-cancer individuals
- 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start30 Nov 2023 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Parasites in Patients With Intestinal CancerStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case-control
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nagwa Ibrahim Selim, Sohag University
- Investigators
- nada a elnady, professor, Study director, Sohag Universityemad e nabil, ass prof, Study chair, Sohag Universitymanal r gaballah, lecturer, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850884
- Sponsor's protocol ID
- Soh-Med-23-04-24MS_
- Status last verified
- Nov 2023
- First submitted
- 30 Apr 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intestinal Parasites in Patients With Intestinal Cancer in Sohag, Egypt.
- ClinicalTrials.gov ID
- NCT05850884
- Acronym / sponsor ID
- Soh-Med-23-04-24MS_
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 Nov 2023 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 9 May 2023 (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.
This study aims to evaluate the intestinal parasitic infections in patients with intestinal cancer in comparison to non-cancer individuals
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | Diagnostic Test: stool examination• One hundred stool samples will be collected from patients with intestinal cancer admitted to Sohag Hospital. |
| group B | – | Diagnostic Test: stool examinationone hundred stool samples will be collected from the control group of patients who attended outpatient clinics |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Case-control study
Key inclusion criteria (1 listed)
- intestinal cancer patients (colorectal cancer, intestinal lymphoma, gastrointestinal stromal tumors, and other malignant variants)
Key exclusion criteria (1 listed)
- patient took antibiotics within the previous four weeks and anti-parasitic drugs within the previous two weeks
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 |
|---|---|---|
| stool examinationEach 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 | Diagnostic test | group A, group B |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: Undecided
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.
nada a elnady, professor study director
Sohag University
emad e nabil, ass prof study chair
Sohag University
manal r gaballah, lecturer study chair
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Parasites in Patients With Intestinal Cancer, run by Sohag University at 1 site in Egypt.
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 1 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 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 nagwa i seleem, dominstrator (01060289117 ext. 002, nagwaibrahim@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the intestinal parasitic infections in patients with intestinal cancer in comparison to non-cancer individuals (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2023.