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Trial registered on ANZCTR


Registration number
ACTRN12618001293257
Ethics application status
Approved
Date submitted
27/06/2018
Date registered
31/07/2018
Date last updated
6/03/2020
Date data sharing statement initially provided
6/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Streamlining lung cancer diagnosis through genomic testing of cytology smears
Scientific title
Streamlining lung cancer diagnosis through genomic testing of cytology smears
Secondary ID [1] 295335 0
None
Universal Trial Number (UTN)
Trial acronym
DEBUTANT study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer 308539 0
Tumour genetics 308541 0
Condition category
Condition code
Cancer 307507 307507 0 0
Lung - Non small cell
Respiratory 307508 307508 0 0
Other respiratory disorders / diseases
Cancer 314797 314797 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients are those presenting for diagnosis of enlarged mediastinal or hilar lymph nodes where a tissue diagnosis of lung cancer is required by Endobronchial Ulrasound Transbronchial Needle aspiration (EBUS TBNA). Patient study involvement duration is just for the length of time required to take the TBNA samples ( 5-10 minutes) and for the blood test, at time of cannulation ( 1-2 minutes).All cases would have maximum number of 5 passes of the TBNA needle into the node as is usual practice. Main outcome measure is comparing DNA yield from samples taken with differing agitations of the needle within the lymph node. Study question would be whether once in the node there is the same amount of tumour after 3 agitations of the needle versus 10 agitations of the needle, while suction was applied to the needle. this will be measured by DNA content on Rapid-on-site-examination slides ( Diff Quik). All patients would have samples collected with both 3 agitations and 10 agitations measuring the amount of DNA for each of these spearately. Patients would still have a SINGLE cell block sample from ALL needle passes plus a PAP stained slide for conventional histology and immunohistochemistry.
Intervention code [1] 301661 0
Diagnosis / Prognosis
Comparator / control treatment
the comparison is between 3 agitations of the TBNA needle and 10 agitations of the needle on alternating passes into the lymph node. There is no control group. All patients will be having the procedure with the objective of diagnosing lung cancer, and there is NIL impact on any treatment decision based on this question. the molecular analysis of the cell block is still the mechanism by which molecular treatment decisions will be made and this is not affected by the analysis of these ROSE slides.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306480 0
DNA content of slides of ROSE slides from EBUS TBNA NEEDLE passes made with 3 agitations of the needle within the node versus slides made with 10 agitations. DNA quantitation ( ng per slide) will be the main outcome measure along with tumour smear cellularity on the ROSE slides. Genomic DNA will be extracted from the entirety of DQ cytology slides using a QIAamp DNA Micro Kit (QIAGEN Inc., Germantown, MD). DNA yields will be measured using a Qubit™ dsDNA BR Assay (Thermo Fisher Scientific, Inc.Waltham, MA).
Timepoint [1] 306480 0
there is only one timepoint in the study ie at the time of diagnosis- all samples processed at that time. Is not a followup study
Primary outcome [2] 306482 0
A different endpoint is to examine which parts of the sample have the most DNA as they are extruded back out of the needle- the first drops out, or the last drops. DNA content of ROSE slides made by comparing the first drops of sample ( to come out of the needle after withdrawal from the patient) versus the last drops of sample ( to come out of the needle after withdrawal from the patient. Measured as ng DNA
Timepoint [2] 306482 0
There is only one timepoint in the study ie at the time of diagnosis- all samples processed at that time. Is not a followup study.
Secondary outcome [1] 348647 0
In a full exploration of Next generation sequencing on these samples , DNA in liquid based cytology media ( including methanol as well as RNA Later) will be analysed for whole exome and whole genome sequencing. the success of these samples will be compared to the original diff quik slides as a way of predicting tumour DNA content in the Liquid based cytology media.
Timepoint [1] 348647 0
There is only one timepoint in the study ie at the time of diagnosis- all samples processed at that time. Is not a followup study.

Eligibility
Key inclusion criteria
Patients with enlarged mediastinal and/ or hilar lymph nodes suggestive of lung cancer requiring EBUS TBNA for tissue diagnosis.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients deemed not suitable for bronchoscopy by their treating clinician
Patients deemed unfit for bronchoscopy on the basis of
• Severe respiratory insufficiency or hypoxia, moderate-to-severe hypoxemia or any degree of hypercarbia
• Continuous use of anticoagulants (eg, heparin, warfarin) ADP-Receptor inhibitors (Clopidogrel), GP-IIB/IIIA- inhibitors (Abciximac), fish oil, etc) which cannot be discontinued.
• Uncorrectable coagulopathy or bleeding diathesis
• Platelet dysfunction or platelet count <100×10
• History of major bleeding with bronchoscopy
• Partial tracheal obstruction or obstruction of the superior vena cava
Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy

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)
We will use a pre printed random order for which needle pass is done first ( whether it be 3 agitations or 10 agitation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
2 ebus tbna needles will be used- one for 3 agitations, one for 10 agitations
Phase
Not Applicable
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis
For a non inferiority study of 3 agitations versus 10 agitations we need 134 patients; outcome measure is DNA yield. A clinically meaningful difference (as shown from our pilot study) was taken as 1000ng, and the standard deviation from our study DNA yield of cytology slides was 1970 ng.
If there is truly no difference between the standard and experimental sampling method, then 134 patients are required to be 90% sure that the lower limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will be above the non-inferiority limit of -1000. Hence we would study 140 patients

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
31/05/2018
Date of last participant enrolment
Anticipated
1/03/2022
Actual
Date of last data collection
Anticipated
1/03/2022
Actual
Sample size
Target
140
Accrual to date
120
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 16076 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 16077 0
Sunshine Coast University Private Hospital - Birtinya
Recruitment hospital [3] 16078 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 16079 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [5] 16080 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 23124 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [2] 29588 0
4215 - Southport
Recruitment postcode(s) [3] 29589 0
4575 - Birtinya
Recruitment postcode(s) [4] 29590 0
2170 - Liverpool
Recruitment postcode(s) [5] 29591 0
3050 - Parkville
Recruitment postcode(s) [6] 29592 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 299924 0
Commercial sector/Industry
Name [1] 299924 0
Olympus Australia
Country [1] 299924 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Womens Hospital
Address
Block 7 Royal Brisbane and Womens Hospital Butterfield Street Herston Qld 4029
Country
Australia
Secondary sponsor category [1] 299292 0
Charities/Societies/Foundations
Name [1] 299292 0
Cancer Council of Queensland
Address [1] 299292 0
553 Gregory Terrace
Fortitude Valley QLD 4006
Country [1] 299292 0
Australia
Secondary sponsor category [2] 299295 0
Charities/Societies/Foundations
Name [2] 299295 0
Cancer Australia
Address [2] 299295 0
PO Box 1201, DICKSON ACT 2602
Country [2] 299295 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300793 0
Royal Brisbane and Womens Hospital Human Research Ethics Committee'
Ethics committee address [1] 300793 0
Ethics committee country [1] 300793 0
Australia
Date submitted for ethics approval [1] 300793 0
29/05/2017
Approval date [1] 300793 0
21/09/2017
Ethics approval number [1] 300793 0
HREC/17/QRBW301

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2821 2821 0 0
/AnzctrAttachments/375444(v27-06-2018-13-30-22)-Final Fielding Next Gen protocol version 3.doc (Protocol)
Attachments [2] 2822 2822 0 0
/AnzctrAttachments/375444-fieldingd_ETHICS APPROVAL.pdf (Ethics approval)
Attachments [3] 2823 2823 0 0
/AnzctrAttachments/375444-picf_non-interventional_self_fielding MASTER RBWH FINAL.doc (Participant information/consent)
Attachments [4] 2824 2824 0 0
/AnzctrAttachments/375444-rccm Fielding et al.pdf (Publication)

Contacts
Principal investigator
Name 84834 0
A/Prof David Fielding
Address 84834 0
Dept Thoracic Medicine James Mayne Building Royal Brisbane and Womens Hospital Butterfield Street Herston Qld 4029
Country 84834 0
Australia
Phone 84834 0
+61736464241
Fax 84834 0
+61736465651
Email 84834 0
david.fielding@health.qld.gov.au
Contact person for public queries
Name 84835 0
David Fielding
Address 84835 0
Dept Thoracic Medicine James Mayne Building Royal Brisbane and Womens Hospital Butterfield Street Herston Qld 4029
Country 84835 0
Australia
Phone 84835 0
+61736464241
Fax 84835 0
+61736465651
Email 84835 0
david.fielding@health.qld.gov.au
Contact person for scientific queries
Name 84836 0
David Fielding
Address 84836 0
Dept Thoracic Medicine James Mayne Building Royal Brisbane and Womens Hospital Butterfield Street Herston Qld 4029
Country 84836 0
Australia
Phone 84836 0
+61736464241
Fax 84836 0
+61736465651
Email 84836 0
david.fielding@health.qld.gov.au

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
7267Study protocol    375444-(Uploaded-18-02-2020-17-41-09)-Study-related document.doc
7268Informed consent form    375444-(Uploaded-18-02-2020-17-42-44)-Study-related document.doc
7269Ethical approval    375444-(Uploaded-18-02-2020-17-43-25)-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.