Crohn DiseasePOCD2017NCT03150238
Surgically Resected Crohn's Disease Patients: Prognostic Factors for Re-operation and New Score Building
An observational study of Crohn Disease, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
The project will consist of a multicentre, prospective, observational study with a total duration of 24 months. Clinical, endoscopic and ultrasound data will be collected in a dedicated database (on IG-IBD Register), which will be used to identify potential clinical, endoscopic and ultrasound risk factors of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- observation of prognostic factors for relapse
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- 13 Apr 2017to 31 May 2019
- 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: Adult patients, with a defined diagnosis of CD, who underwent a surgery for CD in the previous 6 months
Who may be able to join
- Male and female patients aged 18 to 65 years, inclusive
- Diagnosis of Crohn's Disease (CD) for at least 6 months prior to enrolment, by clinical, endoscopic and histopathologic evidence
- First surgery for CD performed less than 6 months before enrolment (no second surgery allowed)
- Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
Who cannot join
- Diagnosis of ulcerative colitis or indeterminate colitis
- Crohn's disease isolated at stomach, duodenum, jejunum, or perianal region, without ileo-colonic involvement
- More than one surgery for luminal CD
- Current stoma or need for ileostomy or colostomy
- Clinically relevant diseases making interpretation of the trial difficult or that would put the patient at risk of severe complications, in the opinion of the investigator
- Inability to provide written informed consent and poor compliance with the schedule of protocol assessments
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Clinico Humanitas
Rozzano, MI, 20089
Federica Furfaro, MD PhD, +390282245555, federica.furfaro@humanitas.it
About this study
Official title: A Multicenter Prospective Cohort Study of Surgically Resected Crohn's Disease Patients Aiming to Identify Prognostic Factors for Re-operation: a New Score
The project will consist of a multicentre, prospective, observational study with a total duration of 24 months. Clinical, endoscopic and ultrasound data will be collected in a dedicated database (on IG-IBD Register), which will be used to identify potential clinical, endoscopic and ultrasound risk factors of re-operation. These data could be merged into a shared score, to stratify patients according to the risk of post-surgical re- operation and to define an optimal therapeutic management in the post- operative period. Approximately 220 adult patients, with a defined diagnosis of CD, who underwent a surgery for CD in the previous 6 months will be enrolled.
Read the detailed description
Patients will be consecutively enrolled in this prospective cross-sectional study, during the first 12 months, and then followed for 12 (minimum) up to 24(maximum) months, depending on date of patients' enrolment (total study length: 2 years). Patients will be stratified according to risk factors and type of treatment carried out in that year
- Conditions
- Crohn Disease
- Being tested
- observation of prognostic factors for relapse
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation of prognostic factors for relapseOther
The identification of the most relevant prognostic factors and the definition of their weight in predict the risk of re-intervention will be the basis for the definition of a combined score
| Study group | Role | What they receive |
|---|---|---|
| Post-operative Crohn Disease patients | Adult patients, with a defined diagnosis of CD, who underwent a surgery for CD in the previous 6 months Receives: Other: observation of prognostic factors for relapse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-operation rate in CD patients who underwent surgery for the first time - Re-operation rate
re-operation rate
Measured: 12 months
Secondary outcomes (1)
Ideation of a new score for the risk of re-operation in CD patients
The identification of the prognostic relevant factor and the evaluation of their specific weight in predicting the risk of re-intervention will be the basis for the ideation of a new score for the risk of re-operation in CD patients.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start13 Apr 2017
- Primary completion31 Jan 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Cross-sectional
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Collaborators
- Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)
- Responsible party
- Sponsor
- Investigators
- Federica Furfaro, MD, phD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150238
- Sponsor's protocol ID
- 1687
- Acronym
- POCD2017
- Status last verified
- May 2017
- First submitted
- 10 May 2017
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: TO BE DETERMINED
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Cohort Study of Surgically Resected Crohn's Disease Patients Aiming to Identify Prognostic Factors for Re-operation: a New Score
- ClinicalTrials.gov ID
- NCT03150238
- Acronym / sponsor ID
- POCD2017 / 1687
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Collaborators
- Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 31 Jan 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 12 May 2017 (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 project will consist of a multicentre, prospective, observational study with a total duration of 24 months. Clinical, endoscopic and ultrasound data will be collected in a dedicated database (on IG-IBD Register), which will be used to identify potential clinical, endoscopic and ultrasound risk factors of re-operation. These data could be merged into a shared score, to stratify patients according to the risk of post-surgical re- operation and to define an optimal therapeutic management in the post- operative period. Approximately 220 adult patients, with a defined diagnosis of CD, who underwent a surgery for CD in the previous 6 months will be enrolled.
Detailed description
Patients will be consecutively enrolled in this prospective cross-sectional study, during the first 12 months, and then followed for 12 (minimum) up to 24(maximum) months, depending on date of patients' enrolment (total study length: 2 years). Patients will be stratified according to risk factors and type of treatment carried out in that year
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-operative Crohn Disease patients | – | Other: observation of prognostic factors for relapseAdult patients, with a defined diagnosis of CD, who underwent a surgery for CD in the previous 6 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients, with a defined diagnosis of CD, who underwent a surgery for CD in the previous 6 months
Key inclusion criteria (4 listed)
- Male and female patients aged 18 to 65 years, inclusive
- Diagnosis of Crohn's Disease (CD) for at least 6 months prior to enrolment, by clinical, endoscopic and histopathologic evidence
- First surgery for CD performed less than 6 months before enrolment (no second surgery allowed)
- Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
Key exclusion criteria (6 listed)
- Diagnosis of ulcerative colitis or indeterminate colitis
- Crohn's disease isolated at stomach, duodenum, jejunum, or perianal region, without ileo-colonic involvement
- More than one surgery for luminal CD
- Current stoma or need for ileostomy or colostomy
- Clinically relevant diseases making interpretation of the trial difficult or that would put the patient at risk of severe complications, in the opinion of the investigator
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 |
|---|---|---|
| observation of prognostic factors for relapseThe identification of the most relevant prognostic factors and the definition of their weight in predict the risk of re-intervention will be the basis for the definition of a combined score | Other | Post-operative Crohn Disease patients |
Primary outcome
Re-operation rate in CD patients who underwent surgery for the first time - Re-operation rate
Time frame: 12 months
re-operation rate
1 secondary outcome
Ideation of a new score for the risk of re-operation in CD patients
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Individual participant dataSharing planned: Undecided. TO BE DETERMINED
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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.
Federica Furfaro, MD, phD principal investigator
Istituto Clinico Humanitas
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 Crohn Disease, run by Istituto Clinico Humanitas at 1 site in Italy.
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 6 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 12 May 2017. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federica Furfaro, MD, PhD (+390282245555, federica.furfaro@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-operation rate in CD patients who underwent surgery for the first time - Re-operation rate (time frame: 12 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 12 May 2017.