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Trial registered on ANZCTR


Registration number
ACTRN12616001413415
Ethics application status
Approved
Date submitted
3/10/2016
Date registered
11/10/2016
Date last updated
11/10/2023
Date data sharing statement initially provided
13/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
An ex vivo investigation into diagnosis of coeliac disease by multiple light-based methods. A proof of principle study towards future development of an in vivo point of care diagnosis device.
Scientific title
An ex vivo investigation into diagnosis of coeliac disease by multiple spectroscopic methods. A proof of principle study towards development of an in vivo point of care diagnosis device.
Secondary ID [1] 290256 0
Nil
Universal Trial Number (UTN)
U1111-1184-1036
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
coeliac disease 300473 0
Condition category
Condition code
Oral and Gastrointestinal 300328 300328 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
During a gastroscopy procedure (that the patient is already undertaking) an additional 2-4 biopsies will be collected from the duodenum. These additional biopsies will be analysed spectroscopically followed by standard histological analysis for diagnosis of coeliac disease. The spectroscopic techniques to be carried out on the biopsied tissue include Raman, near-infrared, mid-infrared and fluorescence spectroscopy. These biopsies will be used to determine if a particular form or combination of spectroscopic techniques is a valid potential method for diagnosis of gastrointestinal illnesses. This procedure will only occur once per patient and should not interfere with the reason for undertaking the gastroscopy and any subsequent diagnoses in the first place. In addition patients will be asked some questions relating to their medical history and medication to check for interfering variables.
Intervention code [1] 296048 0
Diagnosis / Prognosis
Comparator / control treatment
Patients who are undergoing a gastroscopy for reasons not related to coeliac disease diagnosis will be invited to act as controls in this study. Their biopsies will undergo the exact same combination of spectroscopic and histological analysis to ensure they are indeed controls based on the histological results. The histological analysis will act as the comparator to the spectroscopic analysis in this study.
Control group
Active

Outcomes
Primary outcome [1] 299791 0
To determine if a combination of spectroscopic methods can be used to detect the presence/absence of coeliac disease. The sensitivity and selectivity of these methods will be determined using the current "gold standard" for coeliac diagnosis - histological analysis. The first 2/3rds patients will be used in the spectroscopic model development in combination with multivariate data analysis methods and the final 1/3rd of patients biopsies will act as an independent test set.
Timepoint [1] 299791 0
The primary outcome will be established approximately one year into data collection or after 80 patients biopsies have been analysed. The biopsies will be collected from each participant in the study at the time of the scheduled gastroscopy. Spectroscopic analysis will be carried out within 2 hours of the biopsy collection, with the sample then immediately being sent on for histological analysis.
Secondary outcome [1] 328126 0
In addition to the presence/absence of coeliac disease, we would like to determine if the severity of coeliac disease present can be detected using spectroscopic methods with the histological analysis acting as the standard for determining degree of damage to the villi.
Timepoint [1] 328126 0
Approximately 1 year into the study or after 95 patients biopsies have been analysed. The biopsies will be collected from each participant in the study at the time of the scheduled gastroscopy. Spectroscopic analysis will be carried out within 1 week of the biopsy collection, with the sample then immediately being sent on for histological analysis and/or sample destruction.

Eligibility
Key inclusion criteria
Patients already undergoing a gastroscopy for either coeliac disease detection or an unrelated reason (control) are invited for inclusion in this study so that the risk of inclusion in the study is associated with an additional 2-4 biopsies collected rather than the gastroscopic procedure itself.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Minors are excluded from this study.
To minimise the risk of bleeding or infection due to biopsy, patients who are at risk of these complications are excluded from this study such as patients with bleeding disorders, taking anticoagulation medicine or patients who are severely immunocompromised .

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)
The group that the patient will belong to is dependent on the histological results - Coeliac disease present versus control/coeliac disease not detected. The first 2/3rds of patients data will be used as the model development for relating the spectroscopic data to the diagnosis whereas the final 1/3rd of patients will act as a blind test set to determine the sensitivitly and selectivity of the spectroscopic detection methods.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
First 2/3rds of patients will be used as model development and the final 1/3rd of patients will act as an independent test set.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Single group
Other design features
All patients are treated equally with an additional set of biopsies collected and analysed independently of their reason for undergoing a gastroscopy. Involvement in the study will not alter their treatment in any way. Their grouping in the study is dependent on their tissue diagnosis (coeliac disease versus control) and time point at which their biopsy was collected during the study (model set versus test set).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
2-4 biopsies will be collected from 95 patients (190-380 biopsies). Each biopsy will be analysed 5x with each spectroscopic technique studied to give 950-1900 spectra/technique. This would mean model development will contain spectra from ~63 patients, with approximately equal proportions from the control and coeliac diseased tissues. The remaining spectra from ~32 patients will act as the independent test set to determine the diagnostics prediction models sensitivity and selectivity. A subset of the all control samples (n=15) will ideally come from participants who are taking antidepressant to check for significance of false positives with antidepressant use using power analysis. The diagnostic prediction models for the spectroscopic data will be setup using multivariate analysis methods such as partial least squares discriminant analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/10/2016
Actual
11/11/2016
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
95
Accrual to date
46
Final
Recruitment outside Australia
Country [1] 8290 0
New Zealand
State/province [1] 8290 0
Otago

Funding & Sponsors
Funding source category [1] 294624 0
Charities/Societies/Foundations
Name [1] 294624 0
New Zealand Society of Gastroenterology
Country [1] 294624 0
New Zealand
Funding source category [2] 297598 0
University
Name [2] 297598 0
University of Otago Research Grant
Country [2] 297598 0
New Zealand
Primary sponsor type
University
Name
Dunedin School of Medicine, University of Otago
Address
Dunedin School of Medicine
PO Box 56
Dunedin
9054
Country
New Zealand
Secondary sponsor category [1] 293486 0
None
Name [1] 293486 0
Address [1] 293486 0
Country [1] 293486 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296064 0
Health and disability ethics committee, NZ
Ethics committee address [1] 296064 0
Ethics committee country [1] 296064 0
New Zealand
Date submitted for ethics approval [1] 296064 0
09/08/2016
Approval date [1] 296064 0
23/09/2016
Ethics approval number [1] 296064 0
16/CEN/113

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

Contacts
Principal investigator
Name 69366 0
Dr Sara Miller
Address 69366 0
Department of Chemistry,
University of Otago,
P.O. Box 56,
Dunedin
9054
Country 69366 0
New Zealand
Phone 69366 0
+64 21 0279 0500
Fax 69366 0
Email 69366 0
sara.miller@otago.ac.nz
Contact person for public queries
Name 69367 0
Michael Schultz
Address 69367 0
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin
9054
Country 69367 0
New Zealand
Phone 69367 0
+64 3 474 0999
Fax 69367 0
Email 69367 0
michael.schultz@otago.ac.nz
Contact person for scientific queries
Name 69368 0
Keith Gordon
Address 69368 0
Department of Chemistry,
University of Otago,
P.O. Box 56,
Dunedin
9054
Country 69368 0
New Zealand
Phone 69368 0
+64 3 479 7599
Fax 69368 0
Email 69368 0
keith.gordon@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.