Inflammatory Bowel DiseasesMINOTORNCT03751722
Genetic an Functional Studies of Patient With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases, run by University Hospital, Lille at 1 site in France.
Trial summary
The objective of this study is to study the response of macrophages, isolated from patients with ulcerative colitis (Crohn's disease) or Crohn's disease (CD), to 6 candidate enterogenous and their derivatives, depending on the genotype for associated polymorphisms. to the development of IBD Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 630 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2007to 10 Apr 2017
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All outpatients and inpatients from gastroenterology units of adulte and pediatric references centers
Who may be able to join
- patient with definite crohn's disease or ulcerative colitis
Who cannot join
- patient receiving anti-TNF therapy during 14 days before inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to study the response of macrophages, isolated from patients with ulcerative colitis (Crohn's disease) or Crohn's disease (CD), to 6 candidate enterogenous and their derivatives, depending on the genotype for associated polymorphisms. to the development of IBD
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Crohn disease, Ulcerative colitis, genetic makers, cytokines
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
Isolated macrophage response measured by PCR
identification of macrophage activation markers specific analysis of gene expression (by PCR in real time) and / or the production (ELISA) of proinflammatory molecules (IL-6, TNF-1 and IL-8), anti-inflammatory (IL-10) and immunomodulatory (IL4,PPAR -2, MOR)
Measured: Baseline: one session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study startFeb 2007
- Primary completion10 Apr 2017
- Study completion10 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corinne Gower-Rousseau, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751722
- Sponsor's protocol ID
- 2005/0528
- Other IDs
- DGS 2006/0083
- Acronym
- MINOTOR
- Status last verified
- Nov 2018
- First submitted
- 20 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic an Functional Studies of Patient With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03751722
- Acronym / sponsor ID
- MINOTOR / 2005/0528
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Crohn disease, Ulcerative colitis, genetic makers, cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Feb 2007 (actual)
- Primary completion
- 10 Apr 2017 (actual)
- Study completion
- 10 Apr 2017 (actual)
- First posted
- 23 Nov 2018 (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.
The objective of this study is to study the response of macrophages, isolated from patients with ulcerative colitis (Crohn's disease) or Crohn's disease (CD), to 6 candidate enterogenous and their derivatives, depending on the genotype for associated polymorphisms. to the development of IBD
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All outpatients and inpatients from gastroenterology units of adulte and pediatric references centers
Key inclusion criteria (1 listed)
- patient with definite crohn's disease or ulcerative colitis
Key exclusion criteria (1 listed)
- patient receiving anti-TNF therapy during 14 days before inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Isolated macrophage response measured by PCR
Time frame: Baseline: one session
identification of macrophage activation markers specific analysis of gene expression (by PCR in real time) and / or the production (ELISA) of proinflammatory molecules (IL-6, TNF-1 and IL-8), anti-inflammatory (IL-10) and immunomodulatory (IL4,PPAR -2, MOR)
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 23 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Corinne Gower-Rousseau, MD, PhD principal investigator
University Hospital, Lille
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 Inflammatory Bowel Diseases, run by University Hospital, Lille at 1 site in France.
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: finished, as of the sponsor's last update on 23 Nov 2018. 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 France. 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?
Isolated macrophage response measured by PCR (time frame: Baseline: one session). 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 23 Nov 2018.