Crohn DiseaseTARGETNCT04031482
TARGET Registry A Project of the German Network for Intestinal Diseases in Cooperation With Other Corporate Partners
An observational study of Crohn Disease and Ulcerative Colitis, run by Ced Service GmbH.
Trial summary
By capturing possible or known risk factors, it will be possible to recognize connections between these risk factors and the disease, thus obtaining valuable insights into the cause of the disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis, Indeterminate Colitis
- How many people
- 4,400 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Sep 2023
- How long will I take part?
- 5 Years
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Any patient with a confirmed diagnosis of Crohn's disease, ulcerative colitis or indeterminate colitis who is undergoing a targeted therapy is a potential candidate for taking part in the registry.
Who may be able to join
- Confirmed diagnosis of Crohn's disease or Confirmed diagnosis of ulcerative colitis or Confirmed diagnosis of indeterminate colitis (IBDU)
- All types of treatment commensurate with the medical practice, independent of any study
- Age 18-80
- Ongoing or incipient targeted therapies with biologics and/or other targeted therapies (e.g. Janus kinase inhibitors)
- Sufficient ability to communicate in German language
- Patient must be able to recognize the nature, significance and scope of this registry and to act accordingly
- Computer/Tablet/mobile phone with internet access
Who cannot join
- No declaration of consent is given
- Age < 18 and > 80
Trial locations and contacts
No sites are listed yet.
About this study
Official title: TARGET Registry A Project of the German Network for Intestinal Diseases in Cooperation With the German Association of Gastroenterologists in Private Practice (Bng) and Other Corporate Partners
By capturing possible or known risk factors, it will be possible to recognize connections between these risk factors and the disease, thus obtaining valuable insights into the cause of the disease. This in turn facilitates an improved evaluation of the treatment situation as well as influencing future framework conditions for preventive measures and planning treatments. Disease registries are thus crucial for the planning and structuring of health policies.
The present registry protocol serves as a basis for the proper implementation of a registry for patients with chronic inflammatory bowel diseases. It describes the study rationale, objectives, design, participant groups, procedures and evaluation methods. Furthermore, it defines the responsibilities of each person involved in maintaining the registry and also forms the basis for decisions regarding evaluation by the Ethics Committee.
Read the detailed description
In view of the high prevalence and currently unsatisfactory treatment status, there is a significant medical demand for more effective treatment options. These require greater knowledge about the condition in the form of full disease progressions while exposed to a wide range of different treatment concepts and influencing factors. It has been possible to significantly increase scientific understanding of the pathogenesis of ulcerative colitis and Crohn's disease over the last few decades. Clinical and experimental results indicate a causal link with gastrointestinal barrier dysfunction and defective regulation of the immune system. However, no evidence has been found to prove that patients with the disease develop an immune deficiency by themselves, resulting in an increased susceptibility to bacterial or viral infections. Furthermore, there are unanswered questions concerning aetiology, risk factors and influencing factors for the early prediction of treatment responses.
The aim of this registry is to expand on previous findings in the field of diagnostic and therapeutic pathways for patients with Crohn's disease, ulcerative colitis and indeterminate colitis undergoing routine administration of a targeted therapy (biologics or another targeted therapy such as Janus kinase therapy) and various different treatment approaches. A data pool is to be generated for this purpose, in order to
- analyse disease progression
- systematize findings about treatment processes
- identify potential influencing factors
- review any new diagnostic procedures
- identify potential test subjects for further study
- evaluate the safety of various treatment concepts
A specific objective has not been defined for this registry as a registry does not per se need to build upon the foundation of a theoretically-deduced research hypothesis. Rather, it acts as a gateway for generating a systematic data repository.
The registry offers researchers the opportunity to formulate their own research hypotheses based on the collected data and to then use the generated data pool to attempt to test their hypothesis. Additional data/variables could also be collected as necessary in order to answer certain questions.
- Conditions
- Crohn Disease, Ulcerative Colitis, Indeterminate Colitis
- Being tested
- No intervention, only standard care
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, only standard careOther
The aim of this registry is to expand on previous findings in the field of diagnostic and therapeutic pathways for patients with Crohn's disease, ulcerative colitis and indeterminate colitis undergoing routine administration of a targeted therapy (biologics or another targeted therapy such as Janus kinase therapy) and various different treatment approaches. A data pool is to be generated for this purpose, in order to
- analyse disease progression
- systematize findings about treatment processes
- identify potential influencing factors
- review any new diagnostic procedures
- identify potential test subjects for further study
- evaluate the safety of various treatment concepts
| Study group | Role | What they receive |
|---|---|---|
| Ongoing or incipient targeted therapies | Ongoing or incipient targeted therapies with biologics and/or other targeted therapies (e.g. Janus kinase inhibitors) Receives: Other: No intervention, only standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity
harvey bradshaw index
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study startOct 2019 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2023 (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.
- 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
- 4,400 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Ced Service GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra Plachta-Danielzik, PD Dr., Study director, Kompetenznetz Darmerkrankungen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031482
- Sponsor's protocol ID
- Version 1.2
- Acronym
- TARGET
- Status last verified
- Jul 2019
- First submitted
- 22 Jul 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TARGET Registry A Project of the German Network for Intestinal Diseases in Cooperation With the German Association of Gastroenterologists in Private Practice (Bng) and Other Corporate Partners
- ClinicalTrials.gov ID
- NCT04031482
- Acronym / sponsor ID
- TARGET / Version 1.2
- Conditions
- Crohn Disease, Ulcerative Colitis, Indeterminate Colitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,400 participants (estimated)
- Lead sponsor
- Ced Service GmbHUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 24 Jul 2019 (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.
By capturing possible or known risk factors, it will be possible to recognize connections between these risk factors and the disease, thus obtaining valuable insights into the cause of the disease. This in turn facilitates an improved evaluation of the treatment situation as well as influencing future framework conditions for preventive measures and planning treatments. Disease registries are thus crucial for the planning and structuring of health policies.
The present registry protocol serves as a basis for the proper implementation of a registry for patients with chronic inflammatory bowel diseases. It describes the study rationale, objectives, design, participant groups, procedures and evaluation methods. Furthermore, it defines the responsibilities of each person involved in maintaining the registry and also forms the basis for decisions regarding evaluation by the Ethics Committee.
Detailed description
In view of the high prevalence and currently unsatisfactory treatment status, there is a significant medical demand for more effective treatment options. These require greater knowledge about the condition in the form of full disease progressions while exposed to a wide range of different treatment concepts and influencing factors. It has been possible to significantly increase scientific understanding of the pathogenesis of ulcerative colitis and Crohn's disease over the last few decades. Clinical and experimental results indicate a causal link with gastrointestinal barrier dysfunction and defective regulation of the immune system. However, no evidence has been found to prove that patients with the disease develop an immune deficiency by themselves, resulting in an increased susceptibility to bacterial or viral infections. Furthermore, there are unanswered questions concerning aetiology, risk factors and influencing factors for the early prediction of treatment responses.
The aim of this registry is to expand on previous findings in the field of diagnostic and therapeutic pathways for patients with Crohn's disease, ulcerative colitis and indeterminate colitis undergoing routine administration of a targeted therapy (biologics or another targeted therapy such as Janus kinase therapy) and various different treatment approaches. A data pool is to be generated for this purpose, in order to
- analyse disease progression
- systematize findings about treatment processes
- identify potential influencing factors
- review any new diagnostic procedures
- identify potential test subjects for further study
- evaluate the safety of various treatment concepts
A specific objective has not been defined for this registry as a registry does not per se need to build upon the foundation of a theoretically-deduced research hypothesis. Rather, it acts as a gateway for generating a systematic data repository.
The registry offers researchers the opportunity to formulate their own research hypotheses based on the collected data and to then use the generated data pool to attempt to test their hypothesis. Additional data/variables could also be collected as necessary in order to answer certain questions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ongoing or incipient targeted therapies | – | Other: No intervention, only standard careOngoing or incipient targeted therapies with biologics and/or other targeted therapies (e.g. Janus kinase inhibitors) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient with a confirmed diagnosis of Crohn's disease, ulcerative colitis or indeterminate colitis who is undergoing a targeted therapy is a potential candidate for taking part in the registry.
Key inclusion criteria (7 listed)
- Confirmed diagnosis of Crohn's disease or Confirmed diagnosis of ulcerative colitis or Confirmed diagnosis of indeterminate colitis (IBDU)
- All types of treatment commensurate with the medical practice, independent of any study
- Age 18-80
- Ongoing or incipient targeted therapies with biologics and/or other targeted therapies (e.g. Janus kinase inhibitors)
- Sufficient ability to communicate in German language
Key exclusion criteria (2 listed)
- No declaration of consent is given
- Age < 18 and > 80
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 |
|---|---|---|
| No intervention, only standard careThe aim of this registry is to expand on previous findings in the field of diagnostic and therapeutic pathways for patients with Crohn's disease, ulcerative colitis and indeterminate colitis undergoing routine administration of a targeted therapy (biologics or another targeted therapy such as Janus kinase therapy) and various different treatment approaches. A data pool is to be generated for this purpose, in order to * analyse disease progression * systematize findings about treatment processes * identify potential influencing factors * review any new diagnostic procedures * identify potential test subjects for further study * evaluate the safety of various treatment concepts | Other | Ongoing or incipient targeted therapies |
Primary outcome
Disease activity
Time frame: 3 Years
harvey bradshaw index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
Sandra Plachta-Danielzik, PD Dr. study director
Kompetenznetz Darmerkrankungen
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Ulcerative Colitis, run by Ced Service GmbH.
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 7 inclusion and 2 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 29 Jul 2019. 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?
Contact Sonja Buske (+49 4315929575371, s.buske@kompetenznetz-ced.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease activity (time frame: 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 2019.