Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000462583
Ethics application status
Approved
Date submitted
2/04/2024
Date registered
15/04/2024
Date last updated
15/04/2024
Date data sharing statement initially provided
15/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
FAST study: Feasibility ASessment of circulating Tumour DNA (ctDNA) in the diagnosis of advanced lung cancer in patients
Scientific title
FAST study: Feasibility ASessment of circulating Tumour DNA (ctDNA) in the diagnosis of advanced lung cancer in patients
Secondary ID [1] 311872 0
FAST
Universal Trial Number (UTN)
Trial acronym
FAST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer 333426 0
Condition category
Condition code
Cancer 330102 330102 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
40ml of blood will be collected once only by a study nurse for diagnostic test (circulating tumour DNA) from consented eligible patients, as part of their diagnostic work up. Three assays will be used, the comprehensive ctDNA test is a FDA approved test in clinical practice (though not reimbursed in Australia and NZ), The other two assays (lung focussed NGS panel and droplet digital PCR are research use only, although they will be carried out in a clinical laboratory).
Intervention code [1] 328329 0
Diagnosis / Prognosis
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337859 0
Recruitment rate of eligible patients over 12 months
Timepoint [1] 337859 0
At 12 months after the initiation of the study the number of patients recruited will be assessed.
Primary outcome [2] 337861 0
Proportion of patients with reportable ctDNA samples
Timepoint [2] 337861 0
12 months after initiation of study
Secondary outcome [1] 433494 0
Turn around time for assay
Timepoint [1] 433494 0
Time from enrolment to time of assay result availability
Secondary outcome [2] 433727 0
Patient survey of ctDNA acceptability
Timepoint [2] 433727 0
at the time of blood test
Secondary outcome [3] 433728 0
Clinician survey of ctDNA acceptability
Timepoint [3] 433728 0
At the time of the blood test
Secondary outcome [4] 433729 0
Patient survival
Timepoint [4] 433729 0
3 months after enrolment into study.

Eligibility
Key inclusion criteria
1. Participant is willing and able to give informed consent for participation in the trial.
2. Male or female, aged 18 years or above.
3. Radiological advanced lung cancer (distant metastases as per American Joint Committee on Cancer (AJCC) 8th edition Tumour, Nodes, Metastasis (TNM) staging, stage M1a, M1b or M1c)
4. Radiologist confirmed suspicion of malignancy on chest X-Ray (CXR) or computerised tomography (CT) and clinician opinion likely lung cancer primary
5. Not suitable for cytotoxic chemotherapy but fit for molecularly targeted treatment, due to patient comorbidity, performance status or patient preference
6. Unable to pursue molecular testing of a histological sample
a. Due to anatomical location/risk of complications or,
b. Due to patient preference or,
c. Due to insufficient material for molecular testing
7. Life expectancy expected more than 4 weeks
8. In the Investigator’s opinion, is able and willing to comply with all trial requirements.
9. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• European Cooperative Oncology Group Performance status (ECOG PS) 4
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/04/2024
Actual
Date of last participant enrolment
Anticipated
30/04/2026
Actual
Date of last data collection
Anticipated
31/07/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 26230 0
New Zealand
State/province [1] 26230 0

Funding & Sponsors
Funding source category [1] 316214 0
Other
Name [1] 316214 0
Health Research Council
Country [1] 316214 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 318400 0
None
Name [1] 318400 0
Address [1] 318400 0
Country [1] 318400 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315032 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 315032 0
https://ethics.health.govt.nz/about/southern-health-and-disability-ethics-committee/
Ethics committee country [1] 315032 0
New Zealand
Date submitted for ethics approval [1] 315032 0
03/08/2023
Approval date [1] 315032 0
10/01/2024
Ethics approval number [1] 315032 0
18780

Summary
Brief summary
Lung cancer is the leading cause of cancer related death and disproportionately disadvantages Maori both in incidence and mortality rates. In New Zealand, pathological diagnosis and staging can take months and is absent for one out of five patients with lung cancer. Our study aims to develop a blood-based diagnostic test using circulating tumour DNA (ctDNA) to rapidly identify oncogenic mutations so that patients can be started on appropriate, effective treatment sooner. This study will recruit fifty patients with suspected metastatic lung cancer who are unable to obtain a biopsy. Eligible patients will undergo blood-based testing and surveys about the acceptability of the test.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133486 0
Dr Annie Wong
Address 133486 0
Wellington Blood & Cancer Centre, Wellington Regional Hospital, Newtown, Wellington, 6021
Country 133486 0
New Zealand
Phone 133486 0
+64 275575914
Fax 133486 0
Email 133486 0
annie.wong@otago.ac.nz
Contact person for public queries
Name 133487 0
Annie Wong
Address 133487 0
Wellington Blood & Cancer Centre, Wellington Regional Hospital, Newtown, Wellington, 6021
Country 133487 0
New Zealand
Phone 133487 0
+64 4 3855999
Fax 133487 0
Email 133487 0
annie.wong@otago.ac.nz
Contact person for scientific queries
Name 133488 0
Annie Wong
Address 133488 0
Wellington Blood & Cancer Centre, Wellington Regional Hospital, Newtown, Wellington, 6021
Country 133488 0
New Zealand
Phone 133488 0
+64 4 3855999
Fax 133488 0
Email 133488 0
annie.wong@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
Patients have not consented for IPD genomic data to be shared.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22060Study protocol    387607-(Uploaded-02-04-2024-13-18-30)-Study-related document.pdf
22061Ethical approval    387607-(Uploaded-08-04-2024-09-35-39)-Study-related document.pdf
22062Informed consent form    387607-(Uploaded-02-04-2024-13-19-48)-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.