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Trial registered on ANZCTR


Registration number
ACTRN12619000301167
Ethics application status
Approved
Date submitted
22/02/2019
Date registered
27/02/2019
Date last updated
27/02/2019
Date data sharing statement initially provided
27/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Clinical Performance of the ColoSTAT Diagnostic for colorectal cancer biomarkers
Scientific title
A prospective, cross-sectional, multi-centre study to evaluate the clinical performance of the ColoSTAT In Vitro Diagnostic for the detection and evaluation of biomarkers associated with the occurrence of colorectal cancer
Secondary ID [1] 297481 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Early detection of colorectal cancer 311674 0
Condition category
Condition code
Cancer 310297 310297 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This prospective, cross-sectional, multi-centre, blinded clinical trial evaluates the performance of the ColoSTAT as an in vitro diagnostic test (IVD) for the early detection of colorectal cancer. Participants will be recruited from two cohorts: Chort 1, patients recently diagnosed via colonoscopy with colorectal cancer who are progressing to colorectal surgery or neoadjuvant treatment as part of their normal standard of care; Cohort 2, patients with no prior history of colorectal cancer who have been referred for colonoscopy by their consulting physician.
Participants will be asked to donate around 18 mL of blood for use in the ColoSTAT test. Further, if they do not have a valid result from a faecal immunochemical test (FIT) completed within the preceding 6 months, participants will be asked to complete a FIT sample collection using a commercial FIT home collection kit (provided) and return the samples to the study site for shipment to a central laboratory for testing .
Physically, participation in the trial will involve collection of the blood sample for the ColoSTAT test, completion of a home FIT sample collection if needed and return of the completed kit to the the study site. Additionally, information that will be collected at that first visit will comprise: Details of smoking status and age (known risk factors for colorectal cancer), any personal and/or family medical history of colorectal cancer, results from a FIT performed within the previous 6 months and a listing of any concomitant medications. Vital signs, including height, weight, waist circumference, body mass index, blood pressure and heart rate will also be collected and reported. This first Visit is expected to take around 1-2 hour to complete.
Sometime during the period Day 10 through 28 from Visit 1, participants will receive a phone call from the study site to collect information on any adverse event that may have occurred following blood or FIT sample collection. This follow up, phone interview "Visit 2" is expected to take around 30 minutes.
End of study is the date the participant will undergo either surgery/neoadjuvant treatment (Cohort 1) or colonoscopy (Cohort 2) as per standard of care.
Intervention code [1] 313738 0
Diagnosis / Prognosis
Comparator / control treatment
Colonoscopy reports, augmented with pathology information from any associated biopsies, will be used as the diagnostic performance reference in this study. It should be noted that all subjects from Cohort 1 will have been diagnosed positive by colonoscopy prior to recruitment.
Control group
Active

Outcomes
Primary outcome [1] 319201 0
Assessment of the sensitivity of ColoSTAT for detection of colorectal cancers compared with the gold standard - colonoscopy. This is calculated as the % of true colorectal cancers (as defined by colonoscopy) that are correctly classified by the ColoSTAT test.
Timepoint [1] 319201 0
One year from commencement of recruitment.
Primary outcome [2] 319236 0
Assessment of the specificity of ColoSTAT for detection of colorectal cancers compared with the gold standard - colonoscopy. This is calculated as the % of true cancer-negative participants (as defined by colonoscopy) that are correctly classified as negative by the ColoSTAT test.
Timepoint [2] 319236 0
One year after commencement of recruitment
Secondary outcome [1] 367259 0
Sensitivity of ColoSTAT in detecting clinically actionable colorectal neoplasia (colorectal cancer and advanced adenoma) using colonoscopy as the gold standard. This is calculated as the percentage of true cancers and advanced adenomas combined (as determined by colonoscopy) that ColoSTAT classifies correctly.
Timepoint [1] 367259 0
One year from commencement of recruitment.
Secondary outcome [2] 367395 0
Specificity of ColoSTAT in detecting clinically actionable colorectal neoplasia (colorectal cancer and advanced adenoma) using colonoscopy as the gold standard. This is calculated as the percentage of subjects with no indication of cancer or advanced adenoma (as determined by colonoscopy), that are correctly classified as negative by ColoSTAT.
Timepoint [2] 367395 0
One year from commencement of recruitment

Eligibility
Key inclusion criteria
For Cohort 1:
• Participant is diagnosed colonoscopically with colorectal cancer and is progressing to colorectal surgery or neoadjuvant chemo- or radiation therapy within 30 days of enrolment.
• Participant is able to comprehend, sign, and date the written informed consent document to participate in the study.
• Participant is able and willing to be accessible for blood draw prior to surgery.
• Participant is able and willing to provide stool samples according to written instructions provided to them.

For Cohort 2:
• Participant is scheduled to undergo a colonoscopy within 90 days of enrolment.
• Participant is able to comprehend, sign, and date the written informed consent document to participate in the study.
• Participant is able and willing to be accessible for blood draw prior to start of bowel preparation for colonoscopy.
• Participant is able and willing to provide stool samples according to written instructions provided to them.

Minimum age
40 Years
Maximum age
84 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For Cohort 1:
• Participant has any condition which, in the opinion of the investigator should preclude participation in the study.
• Participation in any "interventional" clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the Participant to one or more study groups.

For Cohort 2:
• Participant has any condition which, in the opinion of the investigator should preclude participation in the study.
• Participant has a history of aerodigestive tract cancer.
• Participant has had a prior colorectal resection for any reason other than sigmoid diverticular disease.
• Participant has had overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding).
• Participation in any "interventional" clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the Participant to one or more study groups.



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
Type of endpoint(s)
Statistical methods / analysis
The primary end point for this trial is the performance (Sensitivity and Specificity) of ColoSTAT for the early detection of colorectal cancer using colonoscopy as a reference. The anticipated performance based on published data is, for sensitivity, 73% with a lower bound 95% confidence limit (CL) of >60%. For specificity the anticipated performance is 90% with a lower 95% CL >80%.
For sensitivity, assuming a 73% sensitivity point estimate and using standard routines in SAS V9.4 PROC POWER for a single proportion, the number of participants with colonoscopy-confirmed colorectal cancer required to reject the null hypothesis that sensitivity is 60% in favour of the one-sided alternative (alpha = 0.025), that sensitivity is > 60%. with 90% power is 145 positive participants who also have an unequivocal ColoSTAT result.
Using a similar process for specificity and assuming a specificity point estimate of 90%, it was calculated that, for 90% power, the study will need to recruit at least 145 patients with a colorectal cancer-free diagnosis by colonoscopy and an unequivocal ColoSTAT result.
For study data analysis, the Full Analysis Set (FAS) will include all participants for whom informed consent has been obtained. The Primary Effect Set PES will comprise all Participants in the FAS who have a result for colonoscopy and on whom the ColoSTAT test has been performed. This population (or subsets of this population) will be used to describe all results from the ColoSTAT test. The number of Participants in the FAS set excluded from the PES will be fully described, and reasons for omission documented.
Results will fall into 5 categories described in the table below:
Result No. Investigational Test Colonoscopy Result Interpretation
1. + + True positive (TP)
2. + - False positive (FP)
3. - + False negative (FN)
4. - - True negative (TN)
.5. Test Fail any Test Fail

Sensitivity and specificity will be calculated according to the scheme::
+ve by colonoscopy -ve by colonoscopy
ColoSTAT +ve TP FP
ColoSTAT -ve FN TN
TP + FN FP +TN
ColoSTAT sensitivity will be estimated as 100% X TP/(TP + FN)
ColoSTAT specificity will be estimated as 100% X TN/(FP + TN)

For sensitivity and specificity, 2-sided 95% confidence limits will be determined using the method of Agresti and Coull, implemented in SAS v9.4.
Sensitivity analyses will be performed where all missing and equivocal tests will be included as negative and secondly where all missing and equivocal tests are included as positive.
All analyses will be performed using the PES

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 13234 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [2] 13235 0
The Alfred - Prahran
Recruitment hospital [3] 13236 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 13237 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 25792 0
5112 - Elizabeth Vale
Recruitment postcode(s) [2] 25793 0
3004 - Prahran
Recruitment postcode(s) [3] 25794 0
3050 - Parkville
Recruitment postcode(s) [4] 25795 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 302048 0
Commercial sector/Industry
Name [1] 302048 0
Rhythm Biosciences Limited
Address [1] 302048 0
Bio21 Institute
30 Flemington Road
Parkville
Victoria, 3010
Country [1] 302048 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Vision Tech Bio Pty Ltd
Address
Bio21 Institute
30 Flemington Road
Parkville
Victoria, 3010
Country
Australia
Secondary sponsor category [1] 301857 0
None
Name [1] 301857 0
Address [1] 301857 0
Country [1] 301857 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302730 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 302730 0
Royal Adelaide Hospital
Level 3,
1 Port Rd
Adelaide, SA 5000
Ethics committee country [1] 302730 0
Australia
Date submitted for ethics approval [1] 302730 0
21/01/2019
Approval date [1] 302730 0
24/01/2019
Ethics approval number [1] 302730 0
HREC/18/CALHN/534

Summary
Brief summary
Purpose of study.
To determine if a simple blood sample can be used to accurately test for colorectal cancer

Who is it for?
You may be eligible for this study if you are an adult over 40 years of age who has either been very recently diagnosed with colorectal cancer and is progressing to surgery or is scheduled to undergo a colonoscopy in the next 90 days.

Study details:
All participants in this study will be required to attend a short visit with researchers in order to provide a sample of blood and answer a few questions. Participants will also be asked to provide a faecal sample and give access to their colonoscopy reports. Researchers will then contact participants by phone within a month of the visit for a short check-up.

It is hoped that this research will help determine if a simple blood test is effective in detecting colorectal cancer.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91190 0
Prof Rajvinder Singh
Address 91190 0
Director of Gastroenterology
Lyell McEwin and Modbury Hospitals
Haydown Road
Elizabeth Vale
South Australia, 5112
Country 91190 0
Australia
Phone 91190 0
+61 8 8182 9909
Fax 91190 0
Email 91190 0
rajvinder.singh@sa.gov.au
Contact person for public queries
Name 91191 0
Prof Rajvinder Singh
Address 91191 0
Director of Gastroenterology
Lyell McEwin and Modbury Hospitals
Haydown Road
Elizabeth Vale
South Australia, 5112
Country 91191 0
Australia
Phone 91191 0
+61 8 8182 9909
Fax 91191 0
Email 91191 0
rajvinder.singh@sa.gov.au
Contact person for scientific queries
Name 91192 0
Dr Trevor Lockett
Address 91192 0
Technical Director
Rhythm Biosciences
Bio21 Institute
30 Flemington Road
Parkville
Victoria 3010
Country 91192 0
Australia
Phone 91192 0
+61 (0) 418 647 490
Fax 91192 0
Email 91192 0
trevor.lockett@rhythmbio.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is an Industry initiated study and all data will need to be assessed and evaluated by the sponsor in consultation with the research team before being considered for making publicly available.
What supporting documents are/will be available?
No other documents available
Summary results
No Results