Interleukin 12NCT06844565
Role of IL 12 and IL 23 as Potential Biomarkers in Diagnosis of Early Crohn's Disease
An observational study of Interleukin 12 and Interleukin 23, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the role of Interleukin (IL)-12 and IL-23 as potential biomarkers in the diagnosis of early Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Interleukin 12, Interleukin 23, Biomarker
- What is being tested?
- Immunohistochemistry procedure
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 31 Dec 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective study will be carried out on 110 patients suspected of having Crohn's disease are present in Tanta University Hospitals in the period from January 2021 to December 2023 and the data will be collected in the duration from February 2025 to May 2025 that after approval from the institutional ethical committee.
Who may be able to join
- Age from 18 to 65 years.
- Both sexes.
- Patients who are suspected of having Crohn's disease clinically and by colonoscopy (like ulcers, fistulas, or skip lesions).
- Non-specific ileitis by histopathology.
Who cannot join
- Patients with no pathological samples through colonoscopy.
- History of other significant gastrointestinal diseases (e.g., colon cancer, ischemic bowel disease).
- Immunosuppressive therapy or biologic agents at the time of study.
- Previous abdominal surgeries.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the role of Interleukin (IL)-12 and IL-23 as potential biomarkers in the diagnosis of early Crohn's disease.
Read the detailed description
Crohn's disease (CD) is characterized by periods of remission and relapse, with symptoms ranging from abdominal pain and diarrhea to severe complications such as fistulas and intestinal obstruction.
Interleukins (ILs) are known clusters of cytokines that regulate the proliferation, development, and activation of immune cells. IL-12 is predominantly a pro-inflammatory cytokine secreted by antigen-presenting cells (APC) in response to sensing of microbial components by Toll-like receptors. Another member of this family, IL-23 is also produced by DCs and macrophages after toll-like receptors (TLRs) engagement.
- Conditions
- Interleukin 12, Interleukin 23, Biomarker, Diagnosis, Crohn Disease
- Being tested
- Immunohistochemistry procedure
- Medical subject headings
- Disease, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunohistochemistry procedureProcedure or surgery
Briefly, all slides will be rehydrated, and antigen retrieval will be performed using sodium citrate (pH = 6.0) in a pressure cooker (EDTA buffer, pH = 8.4).
All slides will be blocked with endogenous peroxidase with 3% hydrogen peroxide and blocked non-specific protein with 2.5% bovine serum albumin in phosphate-buffered saline.
If the result shows non-specific ileitis, immunohistochemical staining for IL-12 and IL-23 will be performed using sandwich enzyme-linked immunosorbent assays (ELISA).
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients who are suspected of having Crohn's disease clinically and by colonoscopy (like ulcers, fistulas, or skip lesions). Non-specific ileitis by histopathology. Receives: Procedure: Immunohistochemistry procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of IL-23 to predict Crohn's disease
Sensitivity of IL-23 to predict Crohn's disease will be recorded.
Measured: 6 months after procedure
Secondary outcomes (1)
Sensitivity of IL-12 to predict Crohn's disease
Sensitivity of IL-12 to predict Crohn's disease will be recorded.
Measured: 6 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Jan 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interleukin 12Studies of the same condition, open and under way.
- More trials run by Tanta 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Galal Flefel, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844565
- Sponsor's protocol ID
- 36264PR1059/1/25
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of IL 12 and IL 23 as Potential Biomarkers in Diagnosis of Early Crohn's Disease
- ClinicalTrials.gov ID
- NCT06844565
- Acronym / sponsor ID
- 36264PR1059/1/25
- Conditions
- Interleukin 12, Interleukin 23, Biomarker, Diagnosis, Crohn Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 25 Feb 2025 (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 role of Interleukin (IL)-12 and IL-23 as potential biomarkers in the diagnosis of early Crohn's disease.
Detailed description
Crohn's disease (CD) is characterized by periods of remission and relapse, with symptoms ranging from abdominal pain and diarrhea to severe complications such as fistulas and intestinal obstruction.
Interleukins (ILs) are known clusters of cytokines that regulate the proliferation, development, and activation of immune cells. IL-12 is predominantly a pro-inflammatory cytokine secreted by antigen-presenting cells (APC) in response to sensing of microbial components by Toll-like receptors. Another member of this family, IL-23 is also produced by DCs and macrophages after toll-like receptors (TLRs) engagement.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Immunohistochemistry procedurePatients who are suspected of having Crohn's disease clinically and by colonoscopy (like ulcers, fistulas, or skip lesions). Non-specific ileitis by histopathology. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study will be carried out on 110 patients suspected of having Crohn's disease are present in Tanta University Hospitals in the period from January 2021 to December 2023 and the data will be collected in the duration from February 2025 to May 2025 that after approval from the institutional ethical committee.
Key inclusion criteria (4 listed)
- Age from 18 to 65 years.
- Both sexes.
- Patients who are suspected of having Crohn's disease clinically and by colonoscopy (like ulcers, fistulas, or skip lesions).
- Non-specific ileitis by histopathology.
Key exclusion criteria (4 listed)
- Patients with no pathological samples through colonoscopy.
- History of other significant gastrointestinal diseases (e.g., colon cancer, ischemic bowel disease).
- Immunosuppressive therapy or biologic agents at the time of study.
- Previous abdominal surgeries.
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 |
|---|---|---|
| Immunohistochemistry procedureBriefly, all slides will be rehydrated, and antigen retrieval will be performed using sodium citrate (pH = 6.0) in a pressure cooker (EDTA buffer, pH = 8.4). All slides will be blocked with endogenous peroxidase with 3% hydrogen peroxide and blocked non-specific protein with 2.5% bovine serum albumin in phosphate-buffered saline. If the result shows non-specific ileitis, immunohistochemical staining for IL-12 and IL-23 will be performed using sandwich enzyme-linked immunosorbent assays (ELISA). | Procedure or surgery | Study group |
Primary outcome
Sensitivity of IL-23 to predict Crohn's disease
Time frame: 6 months after procedure
Sensitivity of IL-23 to predict Crohn's disease will be recorded.
1 secondary outcome
Sensitivity of IL-12 to predict Crohn's disease
Time frame: 6 months after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Interleukin 12 and Interleukin 23, run by Tanta 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 25 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of IL-23 to predict Crohn's disease (time frame: 6 months after procedure). 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 25 Feb 2025.