Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000124336
Ethics application status
Approved
Date submitted
1/03/2008
Date registered
10/03/2008
Date last updated
10/03/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Miniprobe confocal laser microscopy for the detection of invisible neoplasia in patients with Barrett´s esophagus
Scientific title
Comparison of confocal laser microscopy (CLM) probe with bioptic histology for detection of neoplasia in patients with Barrett's esophagus
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Barrett esophagus 2896 0
Condition category
Condition code
Oral and Gastrointestinal 3031 3031 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of endoscope guided in vivo miniprobe confocal laser microscopy in the diagnosis of Barrett neoplasia. Each patient will be examined once at their presentation for Barrett surveillance examination.
Intervention code [1] 2626 0
Diagnosis / Prognosis
Comparator / control treatment
CLM recordings from Barrett premarked mucosa with histology obtained from the same sites.
Control group
Active

Outcomes
Primary outcome [1] 3912 0
sensitivity and specificity of miniprobe CLM to detect high grade intraepithelial neoplasia or early esophageal adenocarcinoma using histology as the gold standard.
Timepoint [1] 3912 0
One timepoint, at presentation for screening or surveillance endoscopies.
Secondary outcome [1] 6587 0
interobserver agreement of blindly evaluated CLM recordings.
Timepoint [1] 6587 0
One timepoint, at presentation for screening or surveillance endoscopies.

Eligibility
Key inclusion criteria
All patients with known Barrett esophagus who present for an upper endoscopy (EGD)
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Phase I (establishment of CLM neoplasia criteria) - none.
Phase II (testing of criteria) - only patients with no apparent macroscopic lesions within the Barrett segment.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
39
Accrual to date
Final
Recruitment outside Australia
Country [1] 809 0
Germany
State/province [1] 809 0
13353 Berlin

Funding & Sponsors
Funding source category [1] 3148 0
Self funded/Unfunded
Name [1] 3148 0
Charite University Hospitals Berlin
Country [1] 3148 0
Germany
Primary sponsor type
Hospital
Name
Charite University Hospitals Berlin
Address
Augustenburger Platz 1
Interdisciplinary Endoscopy
13353 Berlin
Country
Germany
Secondary sponsor category [1] 2824 0
Hospital
Name [1] 2824 0
Klinikum Rechts der Isar, TU Munich
Address [1] 2824 0
Medical Clinic II, Gastroenterology
Ismaninger Strasse 22
81675 Munich
Country [1] 2824 0
Germany

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5124 0
Ethikkommission Charite Berlin
Ethics committee address [1] 5124 0
Charite University Hospitals Berlin
Schumannstrasse 20/21
10117 Berlin
Ethics committee country [1] 5124 0
Germany
Date submitted for ethics approval [1] 5124 0
30/06/2005
Approval date [1] 5124 0
01/08/2005
Ethics approval number [1] 5124 0
EA2/179/05

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28417 0
Address 28417 0
Country 28417 0
Phone 28417 0
Fax 28417 0
Email 28417 0
Contact person for public queries
Name 11574 0
Thomas Roesch
Address 11574 0
Augustenburger Platz 1
Charite Campus Virchow
Interdisciplinary Endoscopy
13353 Berlin
Country 11574 0
Germany
Phone 11574 0
+49 30 450553479
Fax 11574 0
Email 11574 0
[email protected]
Contact person for scientific queries
Name 2502 0
[email protected]
Address 2502 0
215 N. Main Street
White River Junction VT 05009
Country 2502 0
United States of America
Phone 2502 0
+1 802 2959363
Fax 2502 0
Email 2502 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.