Crohn Disease (CD)PREDICT-CDNCT07316621
Prospective Risk Evaluation and Detection of Crohn's Disease in First-degree Relatives
An observational study of Crohn Disease (CD), run by GLSMED Learning Health S.A. at 10 sites in 6 countries.
Trial summary
The PREDICT-CD study aims to validate a risk score for the development of Crohn's disease, based on serological biomarkers and lifestyle-related factors. Given that having a family member with the disease is the strongest known risk factor, the target population will consist of first-degree relatives (aged 16 to 35)… Read more about this study
- Who is it for?
- Ages 16 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease (CD)
- How many people
- 10,000 participants
- Where
- 10 sitesin 6 countries
- Study dates
- 1 Apr 2026to 31 Dec 2029
- 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 16 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The first-degree relative without a previous diagnosis of Inflammatory Bowel Disease
Who may be able to join
- Male or female participants, between 16 and 35 years old
- FDR (parent, full-siblings or offspring) from a patient with an established diagnosis of CD
- Participants able to understand the information provided to them and to give written informed assent or consent for the study.
Who cannot join
- Prior diagnosis of IBD
- Any legal or medical condition that limits the information and participation in the study
- Inability to verify CD diagnosis in the proband
- Participants unwilling or unable to provide informed written consent
- Participants unwilling or unable to donate blood for serum
Trial locations and contacts
10 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 6 countries
Portugal4 sites, 4 recruiting
- Recruiting
Hospital Beatriz Ângelo
Lisbon
Catarina Barreiros, MSc, 21 984 7200, Unidade_investigacao_clinica@ulslod.min-saude.pt
Joana Revés, MD
- Recruiting
Hospital da Luz Lisboa
Lisbon
Ana F Raimundo, Ph.D, +351926139262, intecept@hospitaldaluz.pt
Joana Torres, PhD
- Recruiting
Hospital dos Capuchos
Lisbon
Cristina Carvalho, RN, 21 313 6300, ensaiosclinicos@ulssjose.min-saude.pt
Diana Carvalho, MD
- Recruiting
Hospital Santa Maria
Lisbon
Inês Matias, MSc, 210405814, cic@ulssm.min.saude.pt
Sérgio Bronze, MD
Netherlands2 sites, 2 recruiting
- Recruiting
AUMC
Amsterdam
Esmé Clasquin, MSc, (020) 566 9111, intercept.lab@amsterdamumc.nl
Geert d'Haens, PhD
- Recruiting
UMCG
Groningen
Lisa Aboosy, MD, +31 50 361 6161, l.aboosy@umcg.nl
Rinse Weersma, PhD
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma
Francesca Profeta, MSc, 06 30157336, francesca.profeta@policlinicogemelli.it
Franco Scaldaferri, MD
Poland1 site, 1 recruiting
- Recruiting
Państwowy Instytut Medyczny MSWiA w Warszawie
Warsaw
Magdalena Kaniewska, MD, +48 22 162 62 62, magdalena.kaniewska@pimmswia.gov.pl
Grazyna grazyna.rydzewska@pimmswia.gov.pl, MD
Spain1 site, 1 recruiting
- Recruiting
Hospital Galdakao-Usansolo
Galdakao
Iago Rodriguez, PhD, +34 944 00 70 00, ensayos.digestivogaldakao@gmail.com
Iago Rodriguez, PhD
Sweden1 site, 1 recruiting
- Recruiting
Örebro University Hospital
Örebro
Asa Kalvesten, MD, 019 602 10 00, intercept@regionorebrolan.se
Jonas Halfvarsson
About this study
The PREDICT-CD study aims to validate a risk score for the development of Crohn's disease, based on serological biomarkers and lifestyle-related factors. Given that having a family member with the disease is the strongest known risk factor, the target population will consist of first-degree relatives (aged 16 to 35) of individuals diagnosed with Crohn's disease.
This study will be conducted within Work Package 3 (WP3) of the INTERCEPT project, a consortium funded by the Innovative Health Initiative (IHI). The research will take place across 28 centres in seven countries: Portugal, Spain, France, Italy, the Netherlands, Sweden, and Poland.
Read more
To achieve the study objectives, individuals with Crohn's disease (referred to as patients) will be invited to participate and to engage their eligible first-degree relatives. At the baseline visit, the patient's physician will complete a clinical questionnaire covering disease history, treatments, and previous interventions.
At the same time, first-degree relatives (parents, siblings, or children) will donate a blood sample for serum isolation and, optionally, a whole blood and stool sample. They will also complete a questionnaire regarding their health status, habits, and preferences. Follow-up questionnaires will be administered every six months to monitor the onset of symptoms or behavioural changes.
- Conditions
- Crohn Disease (CD)
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| First-degree relatives | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Crohn's disease during the study period
Diagnosis confirmed according to established diagnostic criteria, specifically endoscopy and histopathology
Measured: From enrolment until end of study follow-up (up to 3 years)
Secondary outcomes (4)
Proportion of first-degree relatives classified as high risk according to the PREDICT-CD risk prediction algorithm
Proportion of enrolled first-degree relatives whose calculated risk score exceeds the predefined threshold for high-risk classification, based on the PREDICT-CD risk prediction algorithm incorporating serological biomarkers and lifestyle/environmental risk factors.
Measured: From enrolment until end of study follow-up (up to 3 years)
Clinical and lifestyle characteristics of high-risk individuals who develop inflammatory bowel disease
Characterization of high-risk participants who develop incident inflammatory bowel disease during follow-up, including:
time from study enrolment to diagnosis; disease phenotype and disease behaviour at diagnosis; disease severity at diagnosis; early-life risk factors; dietary, nutritional and lifestyle factors; smoking exposure; medical and surgical history.
Measured: From enrolment until end of study follow-up (up to 3 years)
Incidence of newly diagnosed immune-mediated inflammatory diseases other than Crohn's disease
Number and proportion of participants diagnosed with a new immune-mediated inflammatory disease other than Crohn's disease during study follow-up, based on investigator-confirmed clinical diagnoses.
Measured: From enrolment until end of study follow-up (up to 3 years)
Participant-reported willingness to receive predictive risk information and participate in preventive interventions
Acceptability will be assessed using a study-specific participant questionnaire. The questionnaire will evaluate willingness to receive information regarding Crohn's disease risk, willingness to undergo additional monitoring, willingness to participate in disease-interception or prevention studies, and concerns and preferences related to predictive testing. Responses will be recorded as categorical and Likert-scale measures and summarized descriptively.
Measured: From enrolment until end of study follow-up (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Apr 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GLSMED Learning Health S.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316621
- Sponsor's protocol ID
- PREDICT-CD
- Acronym
- PREDICT-CD
- Status last verified
- Jul 2026
- First submitted
- 5 Dec 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Risk Evaluation and Detection of Crohn's Disease in First-degree Relatives
- ClinicalTrials.gov ID
- NCT07316621
- Acronym / sponsor ID
- PREDICT-CD / PREDICT-CD
- Conditions
- Crohn Disease (CD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- GLSMED Learning Health S.A.University, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 5 Jan 2026 (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 PREDICT-CD study aims to validate a risk score for the development of Crohn's disease, based on serological biomarkers and lifestyle-related factors. Given that having a family member with the disease is the strongest known risk factor, the target population will consist of first-degree relatives (aged 16 to 35) of individuals diagnosed with Crohn's disease.
This study will be conducted within Work Package 3 (WP3) of the INTERCEPT project, a consortium funded by the Innovative Health Initiative (IHI). The research will take place across 28 centres in seven countries: Portugal, Spain, France, Italy, the Netherlands, Sweden, and Poland.
To achieve the study objectives, individuals with Crohn's disease (referred to as patients) will be invited to participate and to engage their eligible first-degree relatives. At the baseline visit, the patient's physician will complete a clinical questionnaire covering disease history, treatments, and previous interventions.
At the same time, first-degree relatives (parents, siblings, or children) will donate a blood sample for serum isolation and, optionally, a whole blood and stool sample. They will also complete a questionnaire regarding their health status, habits, and preferences. Follow-up questionnaires will be administered every six months to monitor the onset of symptoms or behavioural changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First-degree relatives | – | – |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The first-degree relative without a previous diagnosis of Inflammatory Bowel Disease
Key inclusion criteria (3 listed)
- Male or female participants, between 16 and 35 years old
- FDR (parent, full-siblings or offspring) from a patient with an established diagnosis of CD
- Participants able to understand the information provided to them and to give written informed assent or consent for the study.
Key exclusion criteria (5 listed)
- Prior diagnosis of IBD
- Any legal or medical condition that limits the information and participation in the study
- Inability to verify CD diagnosis in the proband
- Participants unwilling or unable to provide informed written consent
- Participants unwilling or unable to donate blood for serum
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
Development of Crohn's disease during the study period
Time frame: From enrolment until end of study follow-up (up to 3 years)
Diagnosis confirmed according to established diagnostic criteria, specifically endoscopy and histopathology
4 secondary outcomes
Proportion of first-degree relatives classified as high risk according to the PREDICT-CD risk prediction algorithm
Time frame: From enrolment until end of study follow-up (up to 3 years)
Clinical and lifestyle characteristics of high-risk individuals who develop inflammatory bowel disease
Time frame: From enrolment until end of study follow-up (up to 3 years)
Incidence of newly diagnosed immune-mediated inflammatory diseases other than Crohn's disease
Time frame: From enrolment until end of study follow-up (up to 3 years)
Participant-reported willingness to receive predictive risk information and participate in preventive interventions
Time frame: From enrolment until end of study follow-up (up to 3 years)
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 29 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Crohn Disease (CD)
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
RecruitingPhase 4
Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease
Crohn Disease (CD)
RecruitingPhase 2
A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
Inflammatory Bowel Diseases, Crohn's Disease
RecruitingPhase 4
A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)
Crohn Disease
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.
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease (CD), run by GLSMED Learning Health S.A. at 10 sites in 6 countries.
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 3 inclusion and 5 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 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Portugal, Netherlands, Italy, Poland, Spain and 1 more country. 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 Ana F Raimundo, PhD (+351 926139262, intercept@hospitaldaluz.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Crohn's disease during the study period (time frame: From enrolment until end of study follow-up (up to 3 years)). 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 29 Jul 2026.