Inflammatory Bowel DiseasesCELESTENCT06256393
Inflammatory Bowel Disease Cohort in Nantes
An observational study of Inflammatory Bowel Diseases, run by Nantes University Hospital at 3 sites in France.
Trial summary
The CELESTE cohort will be a three-center prospective cohort associated with the creation of a biobank including Inflammatory Bowel Diseases (IBD) patients with active disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Collection of biological samples
- How many people
- 360 participants
- Where
- 3 sitesFrance
- Study dates
- 4 Feb 2025to Feb 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: IBD patients who are immunomodulator-naive or refractory to one or more lines of immunosuppressive, biotherapy, or small molecule therapy
Who may be able to join
- Patients over 18 years of age;
- Patients with an established diagnosis of IBD: CD, UC, unclassified IBD or refractory chronic pouchitis;
- Patients with active disease requiring surgery or endoscopy, whether performed at diagnosis or prior to initiation of new therapy;
- Patients who have given written consent to participate in the study and to keep biological samples for research purposes
Who cannot join
- Patients refusing to participate in the cohort;
- Patients with chronic inflammatory bowel disease quiescent at inclusion;
- Patients with a contraindication to general anaesthesia;
- Vulnerable patients (under court protection, curators, guardians);
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
CHU de Nantes
Nantes
Catherine Le Berre, MD, +33240083152, catherine.leberre@chu-nantes.fr
- Not yet recruiting
Clinique Jules Verne
Nantes
Mathurin FLAMANT, MD
- Not yet recruiting
Hopital Privé du Confluent
Nantes
Caroline TRANG, MD
About this study
Official title: Cohorte Nantaise de Maladies Inflammatoires Chroniques Intestinales
The CELESTE cohort will be a three-center prospective cohort associated with the creation of a biobank including Inflammatory Bowel Diseases (IBD) patients with active disease
Read the detailed description
The CELESTE cohort will be a prospective cohort of IBD patients followed up at Nantes University Hospital, Jules Verne Clinic (Nantes) and/or Confluent Private Hospital (Nantes). The multicentric nature of the cohort including a tertiary referral center and two secondary care centers is a major asset, enabling the enrolment of a broad spectrum of patients, from those naïve to any immunomodulatory treatment to those refractory to multiple biologic therapies.
It will be associated with a multi-omics biobank with the aim of identifying new cellular and molecular signatures of success of the therapeutic strategy at one year.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Collection of biological samples
- Keywords
- Crohn's disease, Ulcerative colitis, Cohort, Biocollection pathophysiology
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of biological samplesOther
Collection of blood samples and intestinal biopsies during a surgery or colonoscopy for disease relapse
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients of both sexes, over 18 years of age, with an established diagnosis of IBD (Crohn's desease, ulcerative colitis, unclassified IBD or chronic pouchitis) will be eligible for inclusion in a consultation to schedule surgery or colonoscopy for disease relapse (at diagnosis or prior to initiation of treatment), irrespective of treatment received Receives: Other: Collection of biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who succeed in their therapeutic strategy
Determine the proportion of patients who succeed in their therapeutic strategy at one year
Measured: One year after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start4 Feb 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2031 (estimated)
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 Nantes University HospitalThe 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
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256393
- Sponsor's protocol ID
- RC23_0467
- Acronym
- CELESTE
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohorte Nantaise de Maladies Inflammatoires Chroniques Intestinales
- ClinicalTrials.gov ID
- NCT06256393
- Acronym / sponsor ID
- CELESTE / RC23_0467
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Crohn's disease, Ulcerative colitis, Cohort, Biocollection pathophysiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 13 Feb 2024 (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 CELESTE cohort will be a three-center prospective cohort associated with the creation of a biobank including Inflammatory Bowel Diseases (IBD) patients with active disease
Detailed description
The CELESTE cohort will be a prospective cohort of IBD patients followed up at Nantes University Hospital, Jules Verne Clinic (Nantes) and/or Confluent Private Hospital (Nantes). The multicentric nature of the cohort including a tertiary referral center and two secondary care centers is a major asset, enabling the enrolment of a broad spectrum of patients, from those naïve to any immunomodulatory treatment to those refractory to multiple biologic therapies.
It will be associated with a multi-omics biobank with the aim of identifying new cellular and molecular signatures of success of the therapeutic strategy at one year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Collection of biological samplesPatients of both sexes, over 18 years of age, with an established diagnosis of IBD (Crohn's desease, ulcerative colitis, unclassified IBD or chronic pouchitis) will be eligible for inclusion in a consultation to schedule surgery or colonoscopy for disease relapse (at diagnosis or prior to initiation of treatment), irrespective of treatment received |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- IBD patients who are immunomodulator-naive or refractory to one or more lines of immunosuppressive, biotherapy, or small molecule therapy
Key inclusion criteria (4 listed)
- Patients over 18 years of age;
- Patients with an established diagnosis of IBD: CD, UC, unclassified IBD or refractory chronic pouchitis;
- Patients with active disease requiring surgery or endoscopy, whether performed at diagnosis or prior to initiation of new therapy;
- Patients who have given written consent to participate in the study and to keep biological samples for research purposes
Key exclusion criteria (4 listed)
- Patients refusing to participate in the cohort;
- Patients with chronic inflammatory bowel disease quiescent at inclusion;
- Patients with a contraindication to general anaesthesia;
- Vulnerable patients (under court protection, curators, guardians);
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 |
|---|---|---|
| Collection of biological samplesCollection of blood samples and intestinal biopsies during a surgery or colonoscopy for disease relapse | Other | Patients |
Primary outcome
Proportion of patients who succeed in their therapeutic strategy
Time frame: One year after inclusion
Determine the proportion of patients who succeed in their therapeutic strategy at one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
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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.
3 sites 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 Nantes University Hospital at 3 sites 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 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: looking for participants now, as of the sponsor's last update on 10 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 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Le Berre, MD (+33240083152, catherine.leberre@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who succeed in their therapeutic strategy (time frame: One year after inclusion). 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 10 Feb 2025.