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Trial registered on ANZCTR


Registration number
ACTRN12624000627550
Ethics application status
Approved
Date submitted
26/03/2024
Date registered
14/05/2024
Date last updated
14/05/2024
Date data sharing statement initially provided
14/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Salivary biomarker testing in patients with Barrett's Oesophagus and Oesophageal Cancer
Scientific title
Biomarkers for Barrett’s Oesophagus and neoplastic progression: Finding the proteomic spitting image in adult patients
Secondary ID [1] 311829 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oesophageal cancer 333358 0
Barrett's Oesophagus 333359 0
Condition category
Condition code
Cancer 330041 330041 0 0
Oesophageal (gullet)
Oral and Gastrointestinal 330042 330042 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
This is an exploratory study to evaluate potential proteomic markers in salivary samples. This is novel and is seeking to determine if a panel of salivary biomarkers could assist in the diagnosis of Barrett's oesophagus and its pathological variants, dysplasia and oesophageal adenocarcinoma. Samples (saliva, blood, gastric secretions) will be collected at standard-care encounters. Samples will be collected by a trained research nurse. At each standard-care encounter participants will be asked to contribute blood samples (20-40mls), saliva samples and gastric fluid from your usual endoscopy procedure.
A 'healthy' control group (a) will be compared to other risk-stratified sub-groups of Barrett's neoplasia.
(b) Non-dysplastic Barrett's Oesophagus (BO) group (n=50) – patients with current Barrett's Oesophagus (BO) but without evidence or history of Barrett’s-dysplasia, undergoing endoscopy
(c) Dysplastic BO group (n=50) – patients with current BO and either low-grade or high-grade dysplasia, undergoing endoscopy
(d) Early Oesophageal Adenocarcinoma (OAC) group (n=50) – patients with current BO and evidence of early OAC, undergoing endoscopy
(e) Advanced OAC group (n=50) – patients with current BO and advanced OAC, undergoing either endoscopy, surgery, or non-operative treatment for this
Intervention code [1] 328282 0
Early detection / Screening
Intervention code [2] 328442 0
Diagnosis / Prognosis
Comparator / control treatment
(a) Control group (n=50) – patients without evidence of history of Barrett's Oesophagus (BO) or Oesophageal Adenocarcinoma (OAC), undergoing upper endoscopy at our centre for clinical reasons
Control group
Active

Outcomes
Primary outcome [1] 337799 0
Identify biomarkers (such as proteins, cells, DNA/RNA/miRNA and microorganisms) that correlate with disease stage. This is an exploratory outcome. The proteins analysed in the laboratory from the collected participant samples will assist in identifying which proteins are relevant for different disease stages of the same condition.
Timepoint [1] 337799 0
Samples are collected at baseline before undergoing an endoscopic procedure.
Primary outcome [2] 337800 0
Identify biomarkers (such as proteins, cells, DNA/RNA/miRNA and microorganisms) that correlate with disease stage. This is an exploratory outcome. The proteins analysed in the laboratory from the collected participant samples will assist in identifying which proteins are relevant for different disease stages of the same condition.
Timepoint [2] 337800 0
Samples will be evaluated at Griffith University research lab. They will be transported on the day after they are collected from participants. The lab will undergo testing of samples within 3 weeks. Time to analysis of samples are not relevant for this outcome measure.
Primary outcome [3] 338173 0
Identify biomarkers (such as proteins, cells, DNA/RNA/miRNA and microorganisms) that correlate with disease stage. This is an exploratory outcome. The proteins analysed in the laboratory from the collected participant samples will assist in identifying which proteins are relevant for different disease stages of the same condition.
Timepoint [3] 338173 0
Samples are collected at baseline before undergoing an endoscopic procedure.
Secondary outcome [1] 433358 0
Determine the salivary micro-RNA profile.
Timepoint [1] 433358 0
Assessed on the baseline sample and contributed to the wider exploratory data set.
Secondary outcome [2] 433359 0
Isolate and detect circulating tumour cells (CTCs) levels
Timepoint [2] 433359 0
Samples will be evaluated at Griffith University research lab. They will be transported on the day after they are collected from participants. The lab will undergo testing of samples within 3 weeks. Time to analysis of samples are not relevant for this outcome measure.
Secondary outcome [3] 434802 0
Establish a protocol to isolate and amplify nucleic acids (DNA/RNA) as a biomarker.
Timepoint [3] 434802 0
The protocol will be established at the completion of the study. This is unknown exactly but anticipate approximately 5 years to collect this data to determine this outcome measure.
Secondary outcome [4] 434803 0
This is an additional primary outcome.
Identify biomarkers (such as proteins, cells, DNA/RNA/miRNA and microorganisms) that correlate with disease stage. This is an exploratory outcome. The proteins analysed in the laboratory from the collected participant samples will assist in identifying which proteins are relevant for different disease stages of the same condition.
Timepoint [4] 434803 0
Samples are collected at baseline during an endoscopic procedure.
Secondary outcome [5] 434804 0
Determine the blood micro-RNA profile.
Timepoint [5] 434804 0
Assessed on the baseline sample and contributed to the wider exploratory data set.
Secondary outcome [6] 434805 0
Determine the gastric fluid micro-RNA profile.
Timepoint [6] 434805 0
Assessed on the baseline sample and contributed to the wider exploratory data set.

Eligibility
Key inclusion criteria
• Referral for investigation of reflux symptoms or other suspected gastrointestinal disease, as well as patients with established Barrett’s oesophagus and/or suspected or established oesophageal adenocarcinoma
• Age between 18 and 100 years old
• Willingness to participate for the duration of the trial period
• Provision of written Informed Consent for participation in this study
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients medically unsuitable for further testing or oesophageal screening, as determined by the treating clinician.
• High risk of poor compliance to participate with study requirements or follow-up as assessed by the investigator
• Current illness that will interfere with the collection of saliva, gastric secretions and/or blood samples
• Previous invasive malignancy within 5 years of current diagnosis with the exception of skin cancer other than melanoma.
• Previous cancer treatment in the last 5 years.

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
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Develop a prognostic score incorporating proteomic, DNA methylation, micro-RNA, and CTC data

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2029
Actual
Date of last data collection
Anticipated
28/12/2029
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26328 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 42302 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 316169 0
Hospital
Name [1] 316169 0
Royal Brisbane & Women's Hospital
Country [1] 316169 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane & Women's Hospital
Address
Country
Australia
Secondary sponsor category [1] 318351 0
None
Name [1] 318351 0
Address [1] 318351 0
Country [1] 318351 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314994 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 314994 0
Ethics committee country [1] 314994 0
Australia
Date submitted for ethics approval [1] 314994 0
01/11/2023
Approval date [1] 314994 0
13/02/2024
Ethics approval number [1] 314994 0

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

Contacts
Principal investigator
Name 133358 0
Dr Florian Grimpen
Address 133358 0
RBWH, Level 9 NHB, Butterfield Street, Herston,4029, Queensland
Country 133358 0
Australia
Phone 133358 0
+61 7 36463455
Fax 133358 0
Email 133358 0
[email protected]
Contact person for public queries
Name 133359 0
Kim Ryan
Address 133359 0
RBWH, Level 9 NHB, Butterfield Street, Herston,4029,Queensland
Country 133359 0
Australia
Phone 133359 0
+61 7 36471765
Fax 133359 0
Email 133359 0
[email protected]
Contact person for scientific queries
Name 133360 0
Florian Grimpen
Address 133360 0
RBWH, Level 9 NHB, Butterfield Street, Herston,4029, Queensland
Country 133360 0
Australia
Phone 133360 0
+61 7 36463455
Fax 133360 0
Email 133360 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidentiality and Ethical reasons prevent data sharing from this study


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.