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Trial registered on ANZCTR


Registration number
ACTRN12620000762954
Ethics application status
Approved
Date submitted
25/05/2020
Date registered
27/07/2020
Date last updated
27/07/2020
Date data sharing statement initially provided
27/07/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Molecular Evaluation of Pancreatic Cancer
Scientific title
Endoscopic Ultrasound Molecular Evaluation of Pancreatic Cancer Trial
Secondary ID [1] 301349 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EU-ME-PC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unresectable or metastatic pancreatic ductal adenocarcinoma or recurrent disease 317566 0
Condition category
Condition code
Cancer 315651 315651 0 0
Pancreatic

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
36
Target follow-up type
Months
Description of intervention(s) / exposure
Following diagnostic biopsy (EUS-FNA), verification of eligibility for this study and informed consent, participants will enter the study. Patients may have a further EUS-FNA for the purpose of obtaining fresh frozen tissue if the extracted genetic material is insufficient for detailed analysis. Comprehensive genomic profiling will be performed on biobanked or archival material from the EUS-FNA. The results from this analysis will be reviewed and relayed to the participants treating oncologist. In case of a positive germline mutation, a referral for genetic counseling will be made. Patients will be followed up in the Upper Gastrointestinal Cancer Registry at 12, 24 and 36 months to be assessed for uptake of targeted therapies and overall survival.

In this study, we will also assess the sensitivity and specificity of a previously established molecular diagnosis of PDAC by statistical analysis of the results obtained from the current and previous studies. We have already developed a genetic diagnostic approach for PDAC based on RNA sequencing (unpublished data). This diagnostic signature was subjected to validation using a smaller panel of genes on a NanoString platform (unpublished data). We will assess the utility of this diagnostic signature in confirming the presence of the PDAC tissue used for comprehensive genomic profiling.
Intervention code [1] 317646 0
Not applicable
Comparator / control treatment
No control group
(The fresh frozen tissue collected through EUS-FNA would be the prioritized material for DNA and RNA extraction, whenever it is available. At the end of the study, the quantity and quality of DNA and RNA recovered from each technique will be reported as part of this study)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323888 0
To determine the proportion of patients with locally advanced and metastatic PDAC (A-PDAC) that can have comprehensive genomic profiling using either fresh frozen or archival EUS-FNA material
Timepoint [1] 323888 0
At conclusion of the trial (36 months)
Secondary outcome [1] 383198 0
To determine the proportion of participants that can have treatment recommendations based on comprehensive genomic profiling by reviewing patients' medical records at the Upper GI cancer registry.
Timepoint [1] 383198 0
At 12, 24 and 36 months when medical records are assessed.
Secondary outcome [2] 383199 0
To determine the number of participants that have changes in their treatment based on comprehensive genomic profiling by reviewing patients' medical records at the Upper GI cancer registry.
Timepoint [2] 383199 0
At conclusion of the trial (36 months)
Secondary outcome [3] 383200 0
To assess the sensitivity and specificity of a previously established molecular diagnosis of PDAC by statistical analysis of the results obtained from the current and previous studies.

[We have already developed a genetic diagnostic approach for PDAC based on RNA sequencing (unpublished data). This diagnostic signature was subjected to validation using a smaller panel of genes on a NanoString platform (unpublished data). We will assess the utility of this diagnostic signature in confirming the presence of the PDAC tissue used for comprehensive genomic profiling.]
Timepoint [3] 383200 0
At conclusion of the trial (36 months)
Secondary outcome [4] 383201 0
To study the quantity and quality of DNA and RNA that can be obtained from the various types of fresh frozen and archival PDAC biopsy materials. The quality and quantity of DNA and RNA would be checked through ScreenTape and Agilent Bioanalyzer, respectively. This is a composite secondary outcome and the results obtained from each group of materials, will be statistically analyzed and reported.
Timepoint [4] 383201 0
At conclusion of the trial (36 months)

Eligibility
Key inclusion criteria
1. Adults, age 18 years or over, male or female
2. Locally advanced (unresectable) or metastatic biopsy-proven pancreatic ductal adenocarcinoma (PDAC) based on the NCCN guidelines version 2, 2017 criteria or recurrent disease
3. Tumour tissue available for DNA/RNA extraction
4. ECOG Performance Status 0-2
5. Suitability for chemotherapy
6. Provision of informed consent for participation in the study
7. Life expectancy of at least 3 months from the time of screening as judged by screening investigator.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Operable or borderline resectable pancreatic cancer
2. 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
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This will be a multicentre study seeking to enrol 150 patients of which 100 will be estimated to have sufficient genetic material to perform molecular phenotyping. It is expected that 50 patients with A-PDAC will be screened per year of which 33 will have sufficient genetic material to allow comprehensive genomic profiling.
The co-primary endpoints of the study are to determine the proportion of patients with A-PDAC that can have successful molecular analysis of either fresh frozen or archival EUS-FNA material. We postulate that the proportion of patients who can have successful molecular phenotyping will be substantially higher in the fresh frozen cohort than that in the archival cohort. We expect that most patients will have fresh frozen tissue available as part of the Victorian Pancreatic Cancer Biobank.

Recruitment
Recruitment status
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)
VIC
Recruitment hospital [1] 16734 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 16735 0
The Alfred - Melbourne
Recruitment hospital [3] 16737 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [4] 16738 0
Cabrini Hospital - Prahran - Prahran East
Recruitment hospital [5] 16739 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [6] 16741 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [7] 16742 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [8] 16743 0
Peninsula Oncology Centre - Frankston
Recruitment hospital [9] 16744 0
Epworth Eastern Hospital - Box Hill
Recruitment hospital [10] 16745 0
North Eastern Community Hospital Inc - Campbelltown
Recruitment postcode(s) [1] 30344 0
3168 - Clayton
Recruitment postcode(s) [2] 30345 0
3004 - Melbourne
Recruitment postcode(s) [3] 30347 0
3144 - Malvern
Recruitment postcode(s) [4] 30348 0
3181 - Prahran East
Recruitment postcode(s) [5] 30349 0
3050 - Parkville
Recruitment postcode(s) [6] 30351 0
3065 - Fitzroy
Recruitment postcode(s) [7] 30352 0
3084 - Heidelberg
Recruitment postcode(s) [8] 30353 0
3199 - Frankston
Recruitment postcode(s) [9] 30354 0
3128 - Box Hill
Recruitment postcode(s) [10] 30355 0
5074 - Campbelltown

Funding & Sponsors
Funding source category [1] 305787 0
Hospital
Name [1] 305787 0
Monash Hospital
Address [1] 305787 0
246 Clayton Rd, Clayton VIC 3168
Country [1] 305787 0
Australia
Funding source category [2] 305790 0
University
Name [2] 305790 0
Monash University (VCA)
Address [2] 305790 0
VPCB, 246 Clayton Rd, Clayton VIC 3168
Country [2] 305790 0
Australia
Primary sponsor type
Individual
Name
Dr Daniel Croagh
Address
Department of Surgery
Upper GI and HPB
Monash Medical Centre
246 Clayton Rd, Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 306229 0
None
Name [1] 306229 0
Address [1] 306229 0
Country [1] 306229 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306061 0
Monash Health HREC
Ethics committee address [1] 306061 0
Monash Medical Centre
246 Clayton Rd, Clayton VIC 3168
Ethics committee country [1] 306061 0
Australia
Date submitted for ethics approval [1] 306061 0
18/12/2019
Approval date [1] 306061 0
15/05/2020
Ethics approval number [1] 306061 0
61006

Summary
Brief summary
The aim of this study is to examine the feasibility and potential benefits of routine comprehensive genomic profiling of advanced inoperable pancreatic cancer using fresh endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) material

Who is it for?
You may be eligible to join this study if you are male or female aged 18 years or above who is diagnosed with locally advanced (unresectable) or metastatic biopsy-proven pancreatic ductal adenocarcinoma (PDAC).

Study details
Following diagnostic biopsy (EUS-FNA), verification of eligibility for this study and informed consent, participants will enter the study. Patients may have a further EUS-FNA for the purpose of obtaining fresh frozen tissue if the extracted genetic material is insufficient for detailed analysis. Comprehensive genomic profiling will be performed on biobanked or archival material from the EUS-FNA. The results from this analysis will be reviewed and relayed to the participants treating oncologist. In case of a positive germline mutation, a referral for genetic counselling will be made. Patients will be followed up in the Upper Gastrointestinal Cancer Registry at 12, 24 and 36 months to be assessed for the uptake of targeted therapies and overall survival.

Availability of a reasonably safe and effective tumour sampling technique to provide material for both diagnosis and comprehensive genomic profiling can pave way for the development of precision medicine, thus increasing survival.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102558 0
Dr Daniel Croagh
Address 102558 0
Department of Surgery
Upper GI and HPB
Monash Medical Centre
246 Clayton Rd, Clayton VIC 3168
Country 102558 0
Australia
Phone 102558 0
+6139543 5311
Fax 102558 0
+6139543 3805
Email 102558 0
dan.croagh@gmail.com
Contact person for public queries
Name 102559 0
Dr Daniel Croagh
Address 102559 0
Department of Surgery
Upper GI and HPB
Monash Medical Centre
246 Clayton Rd, Clayton VIC 3168
Country 102559 0
Australia
Phone 102559 0
+6139543 5311
Fax 102559 0
+6139543 3805
Email 102559 0
dan.croagh@gmail.com
Contact person for scientific queries
Name 102560 0
Dr Daniel Croagh
Address 102560 0
Department of Surgery
Upper GI and HPB
Monash Medical Centre
246 Clayton Rd, Clayton VIC 3168
Country 102560 0
Australia
Phone 102560 0
+6139543 5311
Fax 102560 0
+6139543 3805
Email 102560 0
dan.croagh@gmail.com

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?
No other documents available
Summary results
No Results