IBD, Non Invasive Markers,IL6,Lactoferrin,FerritinNCT04670250
The Validity of Novel Non-invasive Inflammatory Markers for Monitoring of Patients With Ulcerative Colitis
An observational study of IBD, Non Invasive Markers,IL6,Lactoferrin,Ferritin, run by Assiut University.
Trial summary
Ulcerative Colitis (UC) is a disease known for repeated relapses and remissions. So, meticulous follow-up is required to individualize treatment plans according to the status of each patient. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- IBD, Non Invasive Markers,IL6,Lactoferrin,Ferritin
- What is being tested?
- non invasive markers
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Dec 2022
- How long will I take part?
- 3 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: All newly diagnosed patients with ulcerative colitis will be included in the study
Who may be able to join
- Patients who are newly diagnosed to be ulcerative colitis. Patients >18 years old.
Who cannot join
- Patients who are >18 years old. Pregnant patients . Patients with colonic malignancies.
About this study
Ulcerative Colitis (UC) is a disease known for repeated relapses and remissions. So, meticulous follow-up is required to individualize treatment plans according to the status of each patient. The currently used investigations are invasive, costy, and carry the risk of several side effects, making it difficult for the patient to adhere to his continuous follow-up.
Aim: To evaluate the viability of fecal lactoferrin, serum ferritin, and IL6 as noninvasive markers for detecting the activity and follow-up the patients of ulcerative colitis during remission.
Read the detailed description
Introduction: Ulcerative Colitis (UC) is a disease known for repeated relapses and remissions. So, meticulous follow-up is required to individualize treatment plans according to the status of each patient. The currently used investigations are invasive, costy, and carry the risk of several side effects, making it difficult for the patient to adhere to his continuous follow-up.
Aim: To evaluate the viability of fecal lactoferrin, serum ferritin, and IL6 as noninvasive markers for detecting the activity and follow-up the patients of ulcerative colitis during remission.
Patients and Methods:
This is a prospective cohort study will include 160 patients. The study will be aMulticenterthat will be held in different Egyptian governorates. The patient must be, firstly, confirmed to be an ulcerative colitis patient by complete physical examination, laboratory evaluation by fecal calprotectin and CRP. Also, colonoscopy will be done for all included patients and they will be classified according to the Modified Mayo Endoscopic Score (MMES). Biopsies will be taken to confirm the diagnosis with histopathological examination. Fecal lactoferrin, S ferritin, and IL6 (the investigated markers) will be conducted for patients with confirmed diagnosis with UC. . All investigations, including colonoscopy, will be done once again after 3 months to follow up the included patients. The results of all tests will be correlated to the clinical and endoscopic findings of included patients to detect a cut off values to be used during remission and activity.
- Being tested
- non invasive markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non invasive markersDiagnostic test
non invasive markers (IL6, serum ferritin, fecal lactoferrin) used for monitoring of newly diagnosed patients with ulcerative colitis
| Study group | Role | What they receive |
|---|---|---|
| newly diagnosed patients with ulcerative colitis | patients who are newly diagnosed to have ulcerative colitis who are above 18 years old,not pregnant and not known to have cancer colon Receives: Diagnostic Test: non invasive markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Validity of Novel Noninvasive Inflammatory Markers for Monitoring of Patients with Ulcerative Colitis.
the outcome will be to replace an invasive method used frequently to evaluate patients with ulcerative colitis like colonoscoy with a non invasive safe and hopfelly accurate method like fecal
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study startJun 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD, Non Invasive Markers,IL6,Lactoferrin,FerritinStudies 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
- 160 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohammed Kamal Eldin Mohammed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670250
- Sponsor's protocol ID
- non invasive markers in IBD
- Status last verified
- Dec 2020
- First submitted
- 10 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity of Novel Non-invasive Inflammatory Markers for Monitoring of Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT04670250
- Acronym / sponsor ID
- non invasive markers in IBD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 17 Dec 2020 (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.
Ulcerative Colitis (UC) is a disease known for repeated relapses and remissions. So, meticulous follow-up is required to individualize treatment plans according to the status of each patient. The currently used investigations are invasive, costy, and carry the risk of several side effects, making it difficult for the patient to adhere to his continuous follow-up.
Aim: To evaluate the viability of fecal lactoferrin, serum ferritin, and IL6 as noninvasive markers for detecting the activity and follow-up the patients of ulcerative colitis during remission.
Detailed description
Introduction: Ulcerative Colitis (UC) is a disease known for repeated relapses and remissions. So, meticulous follow-up is required to individualize treatment plans according to the status of each patient. The currently used investigations are invasive, costy, and carry the risk of several side effects, making it difficult for the patient to adhere to his continuous follow-up.
Aim: To evaluate the viability of fecal lactoferrin, serum ferritin, and IL6 as noninvasive markers for detecting the activity and follow-up the patients of ulcerative colitis during remission.
Patients and Methods:
This is a prospective cohort study will include 160 patients. The study will be aMulticenterthat will be held in different Egyptian governorates. The patient must be, firstly, confirmed to be an ulcerative colitis patient by complete physical examination, laboratory evaluation by fecal calprotectin and CRP. Also, colonoscopy will be done for all included patients and they will be classified according to the Modified Mayo Endoscopic Score (MMES). Biopsies will be taken to confirm the diagnosis with histopathological examination. Fecal lactoferrin, S ferritin, and IL6 (the investigated markers) will be conducted for patients with confirmed diagnosis with UC. . All investigations, including colonoscopy, will be done once again after 3 months to follow up the included patients. The results of all tests will be correlated to the clinical and endoscopic findings of included patients to detect a cut off values to be used during remission and activity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| newly diagnosed patients with ulcerative colitis | – | Diagnostic Test: non invasive markerspatients who are newly diagnosed to have ulcerative colitis who are above 18 years old,not pregnant and not known to have cancer colon |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All newly diagnosed patients with ulcerative colitis will be included in the study
Key inclusion criteria (1 listed)
- Patients who are newly diagnosed to be ulcerative colitis. Patients >18 years old.
Key exclusion criteria (1 listed)
- Patients who are >18 years old. Pregnant patients . Patients with colonic malignancies.
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 |
|---|---|---|
| non invasive markersnon invasive markers (IL6, serum ferritin, fecal lactoferrin) used for monitoring of newly diagnosed patients with ulcerative colitis | Diagnostic test | newly diagnosed patients with ulcerative colitis |
Primary outcome
The Validity of Novel Noninvasive Inflammatory Markers for Monitoring of Patients with Ulcerative Colitis.
Time frame: 18 months
the outcome will be to replace an invasive method used frequently to evaluate patients with ulcerative colitis like colonoscoy with a non invasive safe and hopfelly accurate method like fecal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD, Non Invasive Markers,IL6,Lactoferrin,Ferritin, 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 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 17 Dec 2020. 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?
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?
The Validity of Novel Noninvasive Inflammatory Markers for Monitoring of Patients with Ulcerative Colitis. (time frame: 18 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 17 Dec 2020.