Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001138471
Ethics application status
Approved
Date submitted
18/08/2016
Date registered
22/08/2016
Date last updated
23/06/2024
Date data sharing statement initially provided
10/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Cancer detection with a blood test.
Scientific title
Developing novel blood-based DNA and RNA biomarkers to detect adenocarcinoma by assessing the blood from people.aged 25 years and older, who have recently been diagnosed with prostate, breast, lung, pancreas, gallbladder, biliary tract, duodenal, periampullary, oesophageal or stomach cancer.
Secondary ID [1] 289959 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 299944 0
Breast Cancer 299945 0
Oesophageal cancer 299946 0
Gastric (stomach) cancer 304213 0
Lung cancer 312633 0
Pancreatic cancer 312634 0
Gallbladder cancer 312635 0
Biliary tree cancer 312636 0
Duodenal cancer 312637 0
Periampullary cancer 312638 0
Condition category
Condition code
Cancer 299844 299844 0 0
Breast
Cancer 299845 299845 0 0
Prostate
Cancer 299846 299846 0 0
Oesophageal (gullet)
Cancer 303563 303563 0 0
Stomach
Cancer 311130 311130 0 0
Lung - Non small cell
Cancer 311131 311131 0 0
Pancreatic
Cancer 311132 311132 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Removal of all reference to the Repatriation General Hospital and inclusion of the Noarlunga Health Service.

Patients diagnosed with a primary adenocarcinoma of the lung, pancreas, oesophagus or stomach (n=250 per diagnosis), or one of the more rare types of digestive tract cancers, such as, gallbladder, biliary tract, duodenal and periampullary (n=25 per diagnosis) who attend clinic appointments at Flinders Medical Centre, Noarlunga Health Service, the Queen Elizabeth Hospital, the Royal Adelaide Hospital and Lyell McEwin Hospital will be enrolled into the study after obtaining informed consent.
Blood will be collected through venepuncture (3 x 9mL K3-EDTA tubes and 1 x 8mL serum clot activator tube) by trained nurses prior to any type of cancer treatment (ie. prior to chemotherapy, radiotherapy and surgery). Whole blood samples will be centrifuged, and plasma and serum will be isolated and stored in cryovial aliquots at -80 degrees until analysis for concentrations of methylated BCAT1 and IKZF1 and other novel biomarkers.
For patients that undergo cancer resection prior to chemotherapy or radiotherapy, consent will be asked to obtain some tissue samples from any excess specimen from surgery or biopsy (a cancer specimen and adjacent normal tissue). The collection of this tissue will be stored in the Flinders Medical Centre tissue bank. Tissue will have DNA extracted for analysis of biomarker levels to allow direct comparison to blood biomarker levels within the same patient.
Cancer pathology details (including stage of disease, pathological features, and Gleason Score for prostate cancer) will be recorded. Other blood indicators that have been taken as part of clinical care prior to surgery (such as PSA for prostate cancer) will be recorded. Patients will be interviewed by nurses to record current medications and other medical conditions, as well as any previous cancers.
Levels of methylated BCAT1 and IKZF1 in the blood and surgical tissue will be determined for each cancer type and stage.

Genomic material (DNA or RNA) will be extracted from blood and/or tissue samples for genetic sequencing analysis to uncover genomic locations that are associated with the patient’s tumour, that are commonly found in adenocarcinomas.
Intervention code [1] 295646 0
Diagnosis / Prognosis
Comparator / control treatment
The levels of methylated BCAT1 and IKZF1 in the blood and surgical tissue for each cancer type and stage will be compared to established levels in the blood and tissue of colorectal cancer patients, as well as the established blood levels in people with no cancer. These historical levels were established in the study ACTRN12611000318987 from 2011-2015.
Control group
Historical

Outcomes
Primary outcome [1] 299329 0
The primary outcome will be the levels of methylated BCAT1 and IKZF1 in the blood of people diagnosed with prostate, breast, lung, pancreas oesophageal, stomach cancer, or one of the more rare types of digestive tract cancers, such as, gallbladder, biliary tract, duodenal or periampullary cancer.
Timepoint [1] 299329 0
Blood will be collected at a single timepoint for each participant shortly after enrollment. All collected blood samples will have plasma extracted and frozen at -80 degrees. All frozen plasma samples will be stored until the completion of enrollment (approximately 24 months), and then will be analysed for the levels of methylated BCAT1 and IKZF1 and other novel biomarkers.
Secondary outcome [1] 326856 0
A secondary outcome is to compare the methylated BCAT1 and IKZF1 levels between blood and surgical tissue samples in people with breast, prostate, lung, pancreas, oesophageal cancer or stomach cancer, or one of the more rare types of digestive tract cancers, such as, gallbladder, biliary tract, duodenal or periampullary cancer.
Timepoint [1] 326856 0
Blood will be collected at a single timepoint for each participant shortly after enrollment. All collected blood samples will have plasma extracted and frozen at -80 degrees. If the participant undergoes surgery (prior to undergoing chemotherapy or radiotherapy), any spare cancer and normal tissue at surgery will be collected and will be frozen at -80 degrees. All frozen plasma samples will be analysed for the levels of methylated BCAT1 and IKZF1 and other novel biomarkers at approximately 24 months (at completion of enrollment). All frozen tissue samples will be analysed for the levels of methylated BCAT1 and IKZF1 and other novel biomarkers at approximately 30 months (at completion of surgery). Comparison of blood and tissue biomarker levels will then be performed at approximately 30 months.
Secondary outcome [2] 326857 0
A secondary outcome is to assess the blood and surgical tissue samples from prostate, breast, lung, pancreas, oesophageal and stomach cancer, or one of the more rare types of digestive tract cancers, such as, gallbladder, biliary tract, duodenal or periampullary cancer, for new DNA and RNA biomarkers specific to these cancers,
Timepoint [2] 326857 0
This will occur following the surgery of all eligible patients (approximately 30 months).
Secondary outcome [3] 406039 0
A secondary outcome is to assess the blood samples during treatment of oesophageal and stomach cancer with chemotherapy, for levels of methylated BCAT1 and IKZF1 and other novel biomarkers..
Timepoint [3] 406039 0
Extra blood samples will be collected at 2 monthly intervals up to 6 months during treatment with chemotherapy. All collected blood samples will have plasma extracted and frozen at -80 degrees Celsius. All frozen plasma samples will be will be stored until the completion of sample collection (approximately 48 months after completion of enrolment), and then will be analysed for the levels of methylated BCAT1 and IKZF1 and other novel biomarkers.
Secondary outcome [4] 406040 0
A secondary outcome is to assess the blood samples following completion of initial treatment for oesophageal and stomach cancer, for levels of methylated BCAT1 and IKZF1 and other novel biomarkers..
Timepoint [4] 406040 0
Extra blood samples will be collected at 6 monthly intervals up to 3 years after initial cancer treatment. All collected blood samples will have plasma extracted and frozen at -80 degrees Celcius. All frozen plasma samples will be will be stored until the completion of sample collection (approximately 48 months after completion of enrolment), and then will be analysed for the levels of methylated BCAT1 and IKZF1 and other novel biomarkers.
Secondary outcome [5] 411593 0
A secondary outcome of this study will be to assess the novel blood biomarker positivity rate using the BCAT1 and IKZF1 DNA methylation test, is independent of the genetic profile of the primary adenocarcinomas in a total of 150 gastric and oesophageal cancer samples.
Timepoint [5] 411593 0
Pre-treatment blood and/or tissues will be collected for genetic analysis and stored at -80 degrees C until sent for genetic sequencing. For participants who do not have tissue samples collected fresh at surgery, small samples of paraffin-embedded tissue of biopsy/surgery material stored within pathology archives will be requested retrospectively by the research investigators and collected from the site’s central histology archive after obtaining informed written consent.

Eligibility
Key inclusion criteria
-Male or female aged 25 years or more
-Known diagnosis of primary adenocarcinoma of the prostate, breast, lung, pancreas, oesophagus, stomach or digestive tract cancers (of any pathological stage)
-Ability and willingness to undergo venepuncture procedure
-Patients must be capable of providing satisfactory informed consent
Minimum age
25 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Unable to provide informed consent.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/09/2016
Actual
20/10/2016
Date of last participant enrolment
Anticipated
19/07/2025
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
1300
Accrual to date
577
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 6498 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 13675 0
Noarlunga Health Service - Noarlunga Centre
Recruitment hospital [3] 25177 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [4] 25178 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 25179 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 14062 0
5042 - Bedford Park
Recruitment postcode(s) [2] 26358 0
5168 - Noarlunga Centre
Recruitment postcode(s) [3] 40847 0
5011 - Woodville
Recruitment postcode(s) [4] 40848 0
5000 - Adelaide
Recruitment postcode(s) [5] 40849 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 294336 0
Charities/Societies/Foundations
Name [1] 294336 0
Flinders Medical Centre Foundation
Country [1] 294336 0
Australia
Funding source category [2] 314289 0
Hospital
Name [2] 314289 0
SALHN Research Enquiry Grant Round
Country [2] 314289 0
Australia
Primary sponsor type
Individual
Name
Erin Symonds
Address
Bowel Health Service
c/o Level 3 Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 293173 0
Commercial sector/Industry
Name [1] 293173 0
Clinical Genomics
Address [1] 293173 0
11 Julius Avenue,
North Ryde
NSW 2113
Country [1] 293173 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295755 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 295755 0
Ethics committee country [1] 295755 0
Australia
Date submitted for ethics approval [1] 295755 0
04/04/2016
Approval date [1] 295755 0
20/07/2016
Ethics approval number [1] 295755 0
162.16
Ethics committee name [2] 311224 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [2] 311224 0
Ethics committee country [2] 311224 0
Australia
Date submitted for ethics approval [2] 311224 0
11/04/2022
Approval date [2] 311224 0
09/05/2022
Ethics approval number [2] 311224 0
20.22

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

Contacts
Principal investigator
Name 68346 0
A/Prof Erin Symonds
Address 68346 0
Bowel Health Service
c/o Level 3 Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 68346 0
Australia
Phone 68346 0
+61 8 8404 2813
Fax 68346 0
Email 68346 0
[email protected]
Contact person for public queries
Name 68347 0
Lorraine Sheehan-Hennessy
Address 68347 0
Bowel Health Service c/o Level 2 Flinders Centre for Innovation in Cancer Flinders Medical Centre Flinders Drive Bedford Park SA 5042
Country 68347 0
Australia
Phone 68347 0
+61 8 8204 7403
Fax 68347 0
Email 68347 0
[email protected]
Contact person for scientific queries
Name 68348 0
Erin Symonds
Address 68348 0
Bowel Health Service
c/o Level 3 Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 68348 0
Australia
Phone 68348 0
+61 8 8404 2813
Fax 68348 0
Email 68348 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14985Informed consent form  [email protected] 371322-(Uploaded-04-01-2022-23-36-12)-Study-related document.pdf



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.