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Trial registered on ANZCTR


Registration number
ACTRN12622000904774
Ethics application status
Approved
Date submitted
17/02/2022
Date registered
24/06/2022
Date last updated
24/06/2022
Date data sharing statement initially provided
24/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Endoscopic Ultrasound Molecular Evaluation of Pancreatic Cancer Trial 2
Scientific title
Endoscopic Ultrasound Molecular Evaluation of Pancreatic Cancer Trial 2. A prospective cohort study to assess the utility of EUS-FNA supernatant for the comprehensive molecular profiling of advanced pancreatic cancer.
Secondary ID [1] 306455 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
EU ME PC 2
Linked study record
This study is a follow on study from the Endoscopic Ultrasound Molecular Evaluation of Pancreatic Cancer Trial (ACTRN12620000762954). In this current study the utility of alternative source of genetic material, EUS biopsy supernatant fluid, for the comprehensive molecular profiling of pancreatic cancer will be assessed. If sufficient DNA is able to extracted from this material, the participants will be enrolled in MoST (ACTRN12616000908437) for comprehensive molecular profiling.

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 325292 0
Condition category
Condition code
Cancer 322692 322692 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective cohort study. Participants with advanced pancreatic cancer who have undergone endoscopic ultrasound fine needle biopsy will be eligible to enrol. The supernatant fluid that is left over after processing the endoscopic ultrasound fine needle biopsy (which is normally discarded) will be collected for DNA and RNA extraction as part of this study. If there is sufficient genetic material, the patients will be referred to the MoST study for comprehensive molecular profiling and review at a molecular tumour board which will be conducted according to the standard protocols for this study (ACTRN12616000908437). Thus, participants will need consent to participate in the MoST study for comprehensive molecular profiling. Entry into MoST substudies and long-term follow up and will be conducted according to the usual protocols of the MoST study.

Intervention code [1] 322886 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330494 0
To determine the proportion of patients with advanced pancreatic adenocarcinoma that can have comprehensive molecular profiling using endoscopic ultrasound guided fine needle biopsy supernatant material.
Comprehensive molecular profiling will be considered successful if there is sufficient DNA for the the TSO 500 gene panel can be performed (50ng of DNA with a DNA integrity score of at least 4) and if at least one mutation typical of pancreatic cancer is identified with a mutant allele frequency of at least 1% .
Timepoint [1] 330494 0
The primary outcome will be assessed at the conclusion of the trial (2 years).
Secondary outcome [1] 406419 0
To determine the proportion of participants with advanced pancreatic adenocarcinoma that can have treatment recommendations based on comprehensive genomic profiling using EUS fine needle biopsy supernatant material
This will be assessed as the proportion of patients who are considered to have treatment available that matches a mutational profile revealed in the comprehensive molecular profiling, eg Sotarasib for KRAS G12C mutation irrespective of whether these patients recieve this treatment.
Timepoint [1] 406419 0
This will be assess on completion of the trial (2 years)
Secondary outcome [2] 406420 0
To determine the number of participants with advanced pancreatic cancer that have changes in their treatment based on comprehensive genomic profiling using EUS fine needle biopsy supernatant material
This will be assessed as the proportion of patients who receive a treatment that matches a mutational profile revealed in the comprehensive molecular profiling, eg Sotarasib for KRAS G12C mutation. This data will be collected from MoST or if not available from MoST by telephone follow up with the treating team.
Timepoint [2] 406420 0
This will be assess at three years (at least 1 year after enrolment of the last participant)
Secondary outcome [3] 406421 0
To determine the quantity of DNA obtained from the supernatant using various types of EUS fine needle biopsy needles
Timepoint [3] 406421 0
This will be assess on completion of the trial (2 years)
Secondary outcome [4] 406422 0
To assess the cost of routine comprehensive molecular profiling of pancreatic cancer using EUS fine needle biopsy supernatant material.
This will be assesses by calculating the cost of sample transport, nuclear acid extraction and the cost of CMP (provided by the MoST study)
Timepoint [4] 406422 0
This will be assess on completion of the trial (2 years)
Secondary outcome [5] 406423 0
To assess the sensitivity of a previously established molecular diagnosis of PDAC using EUS fine needle biopsy supernatant material
Timepoint [5] 406423 0
This will be assess on completion of the trial (2 years)
Secondary outcome [6] 410438 0
To determine the quality of DNA obtained from the supernatant using various types of EUS fine needle biopsy needles. This will be assessed with reference to the DNA integrity number (DIN) using the Agilent 2200 TapeStation Analysis Software.
Timepoint [6] 410438 0
This will be assess on completion of the trial (2 years)
Secondary outcome [7] 410439 0
To determine the quantity of RNA obtained from the supernatant using various types of EUS fine needle biopsy needles
Timepoint [7] 410439 0
This will be assess on completion of the trial (2 years)
Secondary outcome [8] 410440 0
To determine the quality of RNA obtained from the supernatant using various types of EUS fine needle biopsy needle. This will be assessed with reference to the RNA integrity number (RIN) using an Agilent Bioanlayzer.
Timepoint [8] 410440 0
This will be assess on completion of the trial (2 years)

Eligibility
Key inclusion criteria
1. Males or females with cytologically proven adenocarcinoma of the pancreas obtained by EUS-FNA. In those with ‘suspicious’ cytology, the diagnosis of pancreatic adenocarcinoma will be made in conjunction with supporting biochemical and radiological data
2. Metastatic, locally advanced (based on the NCCN guidelines version 2, 2017 criteria) or recurrent disease
3. EUS-FNA supernatant available for DNA/RNA extraction.
4. Study participants must be at least 18 years of age at time of screening
5. ECOG Performance Status 0-2
6. Suitability for chemotherapy
7. Able to give signed informed consent
8. Life expectancy of at least 3 months from the time of screening as judged by screening investigator.
9. Willingness to participate in the MoST program (ACTRN12616000908437)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients considered to have operable or borderline resectable pancreatic cancer
2. Patients with Neuroendocrine pancreatic cancers
3. Evidence of systemic disease (cardiovascular, respiratory, renal, hepatic, etc.) that would preclude chemotherapy.
4. Serious medical or psychiatric conditions that might compromise protocol-based management as judged by investigator

Study design
Purpose of the study
Treatment
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
Efficacy
Statistical methods / analysis
Based on the EU ME PC study we expect that comprehensive molecular profiling will be possible in 80% of patients . There we intend to enrol 125 patients with the result that 100 patients will be able to have CMP.
We expect that 100 TSO-500 gene panels should be sufficient to establish the proportion of patients with targetable mutations with a reasonable level of confidence given the expected rate is 20%.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2022
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
30/09/2023
Actual
Sample size
Target
125
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 21764 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 21765 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 21766 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 21767 0
Royal Perth Hospital - Perth
Recruitment hospital [5] 21768 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [6] 21769 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 36819 0
3168 - Clayton
Recruitment postcode(s) [2] 36820 0
2031 - Randwick
Recruitment postcode(s) [3] 36821 0
5000 - Adelaide
Recruitment postcode(s) [4] 36822 0
6000 - Perth
Recruitment postcode(s) [5] 36823 0
4029 - Herston
Recruitment postcode(s) [6] 36824 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 310805 0
Charities/Societies/Foundations
Name [1] 310805 0
PanKind
Country [1] 310805 0
Australia
Primary sponsor type
Hospital
Name
Monash Health Department of Upper GI Surgery
Address
246 Clayton Rd
Clayton 3168
Victoria
Country
Australia
Secondary sponsor category [1] 312048 0
None
Name [1] 312048 0
Address [1] 312048 0
Country [1] 312048 0
Other collaborator category [1] 282168 0
Other Collaborative groups
Name [1] 282168 0
Garvan Institute of Medical Research
Address [1] 282168 0
384 Victoria St, Darlinghurst NSW 2010
Country [1] 282168 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310374 0
Monash Health
Ethics committee address [1] 310374 0
Ethics committee country [1] 310374 0
Australia
Date submitted for ethics approval [1] 310374 0
22/02/2022
Approval date [1] 310374 0
24/04/2022
Ethics approval number [1] 310374 0
RES-22-0000107A

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

Contacts
Principal investigator
Name 117426 0
Dr Daniel Croagh
Address 117426 0
Monash Health
246 Clayton Rd,
Clayton 3168
Victoria
Country 117426 0
Australia
Phone 117426 0
+61 3 95946207
Fax 117426 0
Email 117426 0
daniel.croagh@monashhealth.org
Contact person for public queries
Name 117427 0
Daniel Croagh
Address 117427 0
Monash Health
246 Clayton Rd,
Clayton 3168
Victoria
Country 117427 0
Australia
Phone 117427 0
+61 3 95946207
Fax 117427 0
Email 117427 0
daniel.croagh@monashhealth.org
Contact person for scientific queries
Name 117428 0
Daniel Croagh
Address 117428 0
Monash Health
246 Clayton Rd,
Clayton 3168
Victoria
Country 117428 0
Australia
Phone 117428 0
+61 3 95946207
Fax 117428 0
Email 117428 0
daniel.croagh@monashhealth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification; Request for sequencing data which is performed by collaborators/external parties will need to be made to those entities.
When will data be available (start and end dates)?
Beginning immediately following publication and ending 3 years after publication.
Available to whom?
Researchers who provide a methodologically sound proposal as assessed by the primary sponsor.
Available for what types of analyses?
For any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator (daniel.croagh@monashhealth.org)


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.