NCT01764542

Brief Summary

The purpose of this study is to study development of dysplasia in the ileal mucosa among patients with Ulcerative Colitis and who previous have hade risk factors for developing cellular changes/dysplasia, i.e. previous dysplasia and/or carcinoma in their specimen.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

4.9 years

First QC Date

September 27, 2012

Last Update Submit

April 18, 2016

Conditions

Ulcerative ColitisDysplasiaSurgery

Keywords

Ulcerative colitisdysplasiarisk factorsurgery

Outcome Measures

Primary Outcomes (1)

  • Presence of dysplasia in patients with Ulcerative Colitis and Ileal Pouch-Anal Anastomosis

    The study ends at above mentioned date. After that, microscopic evaluation, statistics and analysis will be done.

    Up to 7 days

Study Arms (1)

Endoscopy and biopsy

OTHER

Endoscopy with biopsy taken Endoscopy and biopsy Blood samples Questionnaire

Procedure: Endoscopy and biopsy

Interventions

Endoscopy and biopsyPROCEDURE

Endoscopy with biopsy of the ileo-anal pouch and the ileo-anal anastomosis Blood samples

Endoscopy and biopsy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • UC (Ulcerative Colitis)
  • IPAA
  • risk factor for dysplasia

You may not qualify if:

  • Not able to give consent
  • CD (Crohns disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Inst for Clinical Sciences, Sahlgrenska University Hospital

Gothenburg, Göteborg, 41685, Sweden

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

EndoscopyBiopsy

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeCytodiagnosisCytological TechniquesClinical Laboratory TechniquesSpecimen HandlingInvestigative Techniques

Study Officials

  • Lars Börjesson, Surgeon

    Department of Surgery, Sahlgrenska, Göteborg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor, Surgeon, MD

Study Record Dates

First Submitted

September 27, 2012

First Posted

January 9, 2013

Study Start

February 1, 2010

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

SE(1)