Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001474347
Ethics application status
Approved
Date submitted
8/03/2017
Date registered
19/10/2017
Date last updated
24/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pancreatic cancer: Understanding Routine Practice and Lifting End Results (PURPLE). A Prospective Pancreatic Cancer Clinical Registry
Scientific title
Pancreatic cancer: Understanding Routine Practice and Lifting End Results (PURPLE). A Prospective Pancreatic Cancer Clinical Registry
Secondary ID [1] 291388 0
Nil Known
Universal Trial Number (UTN)
U1111-1193-9819
Trial acronym
PURPLE Registry
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 302408 0
Newly diagnosed Pancreatic Cancer 302409 0
Metastatic Pancreatic Cancer 302410 0
Condition category
Condition code
Cancer 301982 301982 0 0
Pancreatic

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Years
Description of intervention(s) / exposure
The following end-points will be evaluated in this study: Time to progression from primary diagnosis (TTP). Progression-free survival (PFS). Overall survival (OS). This project is a multi-centre, prospective cohort study that will aim to enrol 800 patients at participating sites. It involves collection of data into the PURPLE registry, linkage and analysis of data via a WEHI developed database. Comprehensive clinicopathological data will be collected, start and stop dates for all systemic therapies will be captured as well as treatment response data for each therapy used, the reason for any change in treatment, and the date of disease progression. Data related to any resection of primary and or metastatic disease will be collected.
Intervention code [1] 297427 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301756 0
Time to progression from primary diagnosis (TTP) will be assessed by treating doctor for up to 3 years at clinician's discretion using MRI scan, CT scan or PET scan or PET-CT scan.
Timepoint [1] 301756 0
Assessed once per year for three years from enrolment. will be assessed by treating doctor for up to 3 years at clinician's discretion using MRI scan, CT scan or PET scan or PET-CT scan.
Primary outcome [2] 303414 0
Progression-free survival (PFS)will be assessed by treating doctor for up to 3 years at clinician's discretion using MRI scan, CT scan or PET scan or PET-CT scan.
Timepoint [2] 303414 0
Once at the starts pf the study and at various timepoints for up to 3 years at clinician's discretion , will be assessed by MRI scan, CT scan or PET scan or PET-CT scan.
Primary outcome [3] 303461 0
Overall survival (OS will be assessed by will be assessed by treating doctor for up to 3 years at clinician's discretion using MRI scan, CT scan or PET scan or PET-CT scan.
Timepoint [3] 303461 0
At the start of the study and during regular clinic visits at the hospital will be assessed by MRI scan, CT scan or PET scan or PET-CT scan.
Secondary outcome [1] 332536 0
To determine the impact of age, on clinicians’ treatment recommendations looking at patient medical records.
Timepoint [1] 332536 0
Assessed once per year for three years from enrolment.
Secondary outcome [2] 333765 0
To determine the impact of co morbidity, on clinicians’ treatment recommendations looking at patient medical records.
Timepoint [2] 333765 0
Assessed once per year for three years from enrolment.
Secondary outcome [3] 333766 0
To identify factors influencing the choice of FOLFOXIRI vs. Abraxane/ Gemcitabine in the first line setting by reviewing patient medical records.
Timepoint [3] 333766 0
Assessed once per year for three years from enrolment.
Secondary outcome [4] 333767 0
To obtain data on the most common chemotherapy regimens prescribed in the first-line setting by reviewing patient medical records
Timepoint [4] 333767 0
Assessed once per year for three years from enrolment.
Secondary outcome [5] 333769 0
To analyze the range of second-line chemotherapy choices for patients by looking at Medical records. .
Timepoint [5] 333769 0
Assessed once per year for three years from enrolment.
Secondary outcome [6] 333770 0
To determine the rate at which adverse events that could be attributed to the treatment regimen occur in routine clinical practice by reviewing medical records
Timepoint [6] 333770 0
Assessed once per year for three years from enrolment.
Secondary outcome [7] 333771 0
To estimate the progression free survival first. and second-line advanced unresectable or metastatic pancreatic cancer patients. By reviewing medical records.
Timepoint [7] 333771 0
Assessed once per year for three years from enrolment.
Secondary outcome [8] 333772 0
To determine the number of patients that receive any treatment and for patients that are not treated the reasons that chemotherapy was not given by reviewing medical records.
Timepoint [8] 333772 0
Assessed once per year for three years from enrolment.
Secondary outcome [9] 333773 0
To determine the range of chemotherapy choices (single or multiple options) given to patients by reviewing patient medical records
Timepoint [9] 333773 0
Assessed once per year for three years from enrolment.
Secondary outcome [10] 333774 0
To determine the duration of treatment in the first and second line setting by reviewing patient medical records.
Timepoint [10] 333774 0
Assessed once per year for three years from enrolment.
Secondary outcome [11] 333775 0
To determine the number of patients undergoing potentially curative resection of distant metastases or alternative interventions by reviewing patient medical records
Timepoint [11] 333775 0
Assessed once per year for three years from enrolment.
Secondary outcome [12] 333819 0
looking at overall survival of first and second-line advanced unresectable or metastatic pancreatic cancer patients.
Timepoint [12] 333819 0
Assessed once per year for three years from enrolment.

Eligibility
Key inclusion criteria
Patients with newly diagnosed pancreatic cancer, with or without metastatic disease
b) Histologically or cytologically confirmed diagnosis of pancreatic cancer
c) Patients aged 18 years or above with any ECOG performance status with pancreatic cancer
d) Patients who are yet to receive treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients that do not have a new diagnosis of pancreatic cancer. .

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
It is anticipated that a sample size of 800 is sufficient to achieve the aim of this study, and to achieve preliminary insights into variation in practice and outcomes across sites. In order to compare clinical outcomes across different subgroups, Kaplan-Meier survival curves will be defined from survival data and constructed using SAS (registered trademark) software. The stratified log rank test will be used to compare survival curves between different groups of participants. P-values of 0.05 will be considered significant. Due to the non-randomised nature of such comparisons propensity score techniques will be used to balance comparison groups according to baseline factors.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/02/2017
Date of last participant enrolment
Anticipated
31/07/2020
Actual
Date of last data collection
Anticipated
31/07/2023
Actual
Sample size
Target
800
Accrual to date
740
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 7611 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 7612 0
Western Hospital - Footscray - Footscray
Recruitment hospital [3] 7613 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [4] 7614 0
Box Hill Hospital - Box Hill
Recruitment hospital [5] 7615 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [6] 7616 0
Epworth Richmond - Richmond
Recruitment hospital [7] 7617 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [8] 7618 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [9] 7619 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [10] 7620 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [11] 7621 0
The Alfred - Prahran
Recruitment hospital [12] 7622 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment hospital [13] 7623 0
Goulburn Base Hospital - Goulburn
Recruitment hospital [14] 7624 0
The Northern Hospital - Epping
Recruitment hospital [15] 7625 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [16] 7626 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [17] 7627 0
Gold Coast University Hospital - Southport
Recruitment hospital [18] 7628 0
The Canberra Hospital - Garran
Recruitment hospital [19] 7629 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [20] 7630 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [21] 7631 0
Prince of Wales Hospital - Randwick
Recruitment hospital [22] 7632 0
Liverpool Hospital - Liverpool
Recruitment hospital [23] 7633 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [24] 7634 0
Southern Highlands Private Hospital - Bowral
Recruitment hospital [25] 7635 0
Westmead Hospital - Westmead
Recruitment hospital [26] 7636 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [27] 7637 0
John Hunter Hospital - New Lambton
Recruitment hospital [28] 7638 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [29] 7639 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [30] 7640 0
Royal Hobart Hospital - Hobart
Recruitment hospital [31] 7641 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [32] 7642 0
Wellington Health Service - Wellington
Recruitment postcode(s) [1] 15534 0
2031 - Randwick
Recruitment postcode(s) [2] 15541 0
2050 - Camperdown
Recruitment postcode(s) [3] 15538 0
2145 - Westmead
Recruitment postcode(s) [4] 15535 0
2170 - Liverpool
Recruitment postcode(s) [5] 15539 0
2298 - Waratah
Recruitment postcode(s) [6] 15540 0
2305 - New Lambton
Recruitment postcode(s) [7] 15536 0
2560 - Campbelltown
Recruitment postcode(s) [8] 15537 0
2576 - Bowral
Recruitment postcode(s) [9] 15526 0
2580 - Goulburn
Recruitment postcode(s) [10] 15531 0
2605 - Garran
Recruitment postcode(s) [11] 15545 0
2820 - Wellington
Recruitment postcode(s) [12] 15514 0
3000 - Melbourne
Recruitment postcode(s) [13] 15524 0
3004 - Prahran
Recruitment postcode(s) [14] 15516 0
3011 - Footscray
Recruitment postcode(s) [15] 15515 0
3050 - Parkville
Recruitment postcode(s) [16] 15522 0
3065 - Fitzroy
Recruitment postcode(s) [17] 15527 0
3076 - Epping
Recruitment postcode(s) [18] 15523 0
3084 - Heidelberg
Recruitment postcode(s) [19] 15519 0
3121 - Richmond
Recruitment postcode(s) [20] 15517 0
3128 - Box Hill
Recruitment postcode(s) [21] 15518 0
3144 - Malvern
Recruitment postcode(s) [22] 15521 0
3165 - East Bentleigh
Recruitment postcode(s) [23] 15520 0
3168 - Clayton
Recruitment postcode(s) [24] 15528 0
3220 - Geelong
Recruitment postcode(s) [25] 15525 0
3350 - Ballarat Central
Recruitment postcode(s) [26] 15529 0
4029 - Herston
Recruitment postcode(s) [27] 15530 0
4215 - Southport
Recruitment postcode(s) [28] 15532 0
5011 - Woodville
Recruitment postcode(s) [29] 15533 0
5042 - Bedford Park
Recruitment postcode(s) [30] 15542 0
6008 - Subiaco
Recruitment postcode(s) [31] 15544 0
6150 - Murdoch
Recruitment postcode(s) [32] 15543 0
7000 - Hobart
Recruitment outside Australia
Country [1] 8720 0
Singapore
State/province [1] 8720 0
Singapore
Country [2] 8721 0
United Kingdom
State/province [2] 8721 0
London
Country [3] 8722 0
Hong Kong
State/province [3] 8722 0
hong kong

Funding & Sponsors
Funding source category [1] 295861 0
Other
Name [1] 295861 0
Hemstritch Philanthropic fund
Country [1] 295861 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Walter & Eliza Hall Institute
Address
1G Royal Parade
Parkville 3050 Victoria Australia
Country
Australia
Secondary sponsor category [1] 294726 0
None
Name [1] 294726 0
Address [1] 294726 0
Country [1] 294726 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297144 0
MELBOURNE HEALTH HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 297144 0
Office for Research
The Royal Melbourne Hospital
Level 2 South West
300 Grattan Street
Parkville VIC 3050 Victoria Australia
Ethics committee country [1] 297144 0
Date submitted for ethics approval [1] 297144 0
27/07/2016
Approval date [1] 297144 0
30/08/2016
Ethics approval number [1] 297144 0
2016.200

Summary
Brief summary
This project is non-interventional registry of the treatment and outcomes of patients with pancreatic cancer managed at hospitals enrolled to participate in Australia.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have been newly diagnosed with pancreatic cancer (with or without metastatic disease) , with any ECOG performance status and are yet to receive treatment.

Study details
This registry will capture data on presentation and the disease course of pancreatic cancer, surgical interventions for primary and metastatic disease, prescription of systemic therapies, and information regarding multi-disciplinary management and outcomes of this disease in the routine clinical practice setting. This project will collect clinical data using the already established data collection and analysis resources built up over the last 15 years in the Systems Biology & Personalised Medicine Division of the Walter & Eliza Hall Institute of medical research (WEHI). This protocol aims to enrol at least 800 eligible patients over 10 years.
Findings from analyses that occur as part of this project are anticipated to improve our understanding of the presentation, clinical course and management of pancreatic cancer in Australia and other participating countries.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73118 0
A/Prof Peter Gibbs
Address 73118 0
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade, Parkville VIC 3052 Australia
Country 73118 0
Australia
Phone 73118 0
+61 3 93424269
Fax 73118 0
+61 3 93452317
Email 73118 0
Peter.Gibbs@mh.org.au
Contact person for public queries
Name 73119 0
Dr Belinda Lee
Address 73119 0
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade, Parkville VIC 3052 Australia
Country 73119 0
Australia
Phone 73119 0
+61 3 9845 2853
Fax 73119 0
+61 3 93452317
Email 73119 0
Belinda.Lee@mh.org.au
Contact person for scientific queries
Name 73120 0
Dr Belinda Lee
Address 73120 0
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade, Parkville VIC 3052 Australia
Country 73120 0
Australia
Phone 73120 0
+61 3 9845 2853
Fax 73120 0
+61 3 93452317
Email 73120 0
Belinda.Lee@mh.org.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseUse and outcomes of chemotherapy for metastatic pancreatic cancer in Australia.2022https://dx.doi.org/10.1111/imj.15094
EmbaseUse and outcomes from neoadjuvant chemotherapy in borderline resectable pancreatic ductal adenocarcinoma in an Australasian population.2023https://dx.doi.org/10.1111/ajco.13807
N.B. These documents automatically identified may not have been verified by the study sponsor.