TARGET Registry A Project of the German Network for Intestinal Diseases in Cooperation With Other Corporate Partners

NCT04031482 | Unknown

• 1 other identifier: Version 1.2
• Study Type: observational
• Target: 4,400
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Crohn Disease; Ulcerative Colitis; Indeterminate Colitis

Outcome Measures

Primary Outcomes (1)

• Disease activity

  harvey bradshaw index

  3 Years

Other Outcomes (5)

• Quality of life (QOL)

  3 Years

• Use of glucocorticoids

  3 Years

• Need for surgery

  3 Years

Study Arms (1)

Ongoing or incipient targeted therapies

Ongoing or incipient targeted therapies with biologics and/or other targeted therapies (e.g. Janus kinase inhibitors)

Other: No intervention, only standard care

Interventions

No intervention, only standard care OTHER

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

Ongoing or incipient targeted therapies

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• No declaration of consent is given
• Age \< 18 and \> 80

Sponsors & Collaborators

• Ced Service GmbH: lead

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Sandra Plachta-Danielzik, PD Dr.

  Kompetenznetz Darmerkrankungen

  STUDY DIRECTOR

Central Study Contacts

Sonja Buske

CONTACT

+49 4315929575371; s.buske@kompetenznetz-ced.de

Sandra Plachta-Danielzik, PD Dr.

CONTACT

+49 4315929575371; splachta-danielzik@kompetenznetz-ced.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 24, 2019
• Study Start: October 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: July 29, 2019

Record last verified: 2019-07