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Trial registered on ANZCTR


Registration number
ACTRN12612000763842
Ethics application status
Not yet submitted
Date submitted
12/07/2012
Date registered
18/07/2012
Date last updated
18/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to investigate whether a biomarker in the blood can predict cancer recurrence in patients with pancreatic cancer
Scientific title
A study to investigate the potential use of circulating tumour DNA as a marker of residual disease that predicts later recurrence in patients diagnosed with stage I and II pancreatic adenocarcinoma
Secondary ID [1] 280837 0
nil
Universal Trial Number (UTN)
U1111-1132-5971
Trial acronym
ctDNA in Pancreatic Cancer
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic adenocarcinoma 286904 0
Condition category
Condition code
Cancer 287223 287223 0 0
Pancreatic

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a prospective study involving the collection of blood samples for the purposes of measuring circulating tumour DNA from patients with pancreatic adenocarcinoma who are planned to undergo surgical resection
Patients will be treated and followed according to standard protocols.
This is an exploratory, prospective study enrolling patients diagnosed with stage I and II pancreatic adenocarcinoma to investigate the potential use of a novel blood-based biomarker (circulating tumour DNA) as a marker of residual disease that predicts later recurrence. Blood collection will occur at two timepoints as follows:
Timepoint 1: Baseline - Presurgery
Timepoint 2: 4 - 8 Weeks post surgery
Intervention code [1] 285257 0
Not applicable
Comparator / control treatment
Uncontrolled.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287506 0
To demonstrate that persistence of tumour derived DNA in peripheral blood following complete resection of the primary tumour is a sensitive and specific marker of subsequent disease recurrence.
Timepoint [1] 287506 0
At the completion of analysis of blood, plasma and tissue samples.

Study participants will have 15 mls of blood collected at 2 time points:
Time point 1: Pre-surgery
Time point 2: 4 - 8 weeks post surgery
Secondary outcome [1] 298296 0
To demonstrate that the disappearance of tumour DNA in peripheral blood is a sensitive and specific marker of benefit from adjuvant chemotherapy.
Timepoint [1] 298296 0
At the completion of analysis of blood and plasma samples.

Study participants will have 15 mls of blood collected at 2 time points:
Time point 1: Pre-surgery
Time point 2: 4 - 8 weeks post surgery
Secondary outcome [2] 298297 0
To explore the potential of the appearance or re-appearance of ctDNA of tumour DNA in peripheral blood as a specific and sensitive marker of disease recurrence.
Timepoint [2] 298297 0
At the completion of analysis of blood and plasma samples.

Study participants will have 15 mls of blood collected at 2 time points:
Time point 1: Pre-surgery
Time point 2: 4 - 8 weeks post surgery

Eligibility
Key inclusion criteria
1. Patients with resectable pancreatic adenocarcinoma who are to have a resection of their tumour.
2. ECOG performance status 0 - 2.
3. Patients willing to provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of another primary cancer within the last 5 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix.
2. Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol.
3. Patients that are not accessible for follow-up.
4. Preoperative chemotherapy or radiotherapy.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet 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)

Funding & Sponsors
Funding source category [1] 285623 0
Other Collaborative groups
Name [1] 285623 0
Ludwig Institute for Cancer Research
Address [1] 285623 0
PO Box 2008
RMH Post Office
PARKVILLE, VIC., 3050
AUSTRALIA
Country [1] 285623 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Ludwig Institute for Cancer Research
Address
PO Box 2008
RMH Post Office
PARKVILLE, VIC., 3050
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 284456 0
None
Name [1] 284456 0
Address [1] 284456 0
Country [1] 284456 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287618 0
Melbourne Health HREC
Ethics committee address [1] 287618 0
Post Office
Royal Melbourne Hospital
Parkville, Victoria, 3050
Ethics committee country [1] 287618 0
Australia
Date submitted for ethics approval [1] 287618 0
30/04/2012
Approval date [1] 287618 0
Ethics approval number [1] 287618 0

Summary
Brief summary
The aim of this study is to work towards developing a diagnostic technique to determine patients response to chemotherapy and surgery using circulating tumour (ct) DNA biomarkers. This will reduce the need for excessive chemotherapy treatment therefore reducing the unwanted adverse effects of treatments.

Genes are substances in the body which contain information about characteristics about us as indivuals. Previous studies have found that the majority (more than 9 out of 10) of pancreataic cancers contain a mutation in KRAS gene which can be detected in the blood.

Identifying biomarkers are important because: they may be linked with disease progression; they may help to identify people who are most likely to benefit from a certain treatment such as chemotherapy and how much treatment they need; and they help to identify people who have partial or complete response to treatment without the need for chemotherapy after surgery
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34429 0
Address 34429 0
Country 34429 0
Phone 34429 0
Fax 34429 0
Email 34429 0
Contact person for public queries
Name 17676 0
Philippa Robertson
Address 17676 0
Ludwig Institute for Cancer Research

PO Box 2008
RMH Post Office
PARKVILLE, VIC., 3050
Country 17676 0
Australia
Phone 17676 0
+61 (3)9342 4584
Fax 17676 0
Email 17676 0
philippa.robertson@ludwig.edu.au
Contact person for scientific queries
Name 8604 0
Dr Lara Lipton
Address 8604 0
Ludwig Institute for Cancer Research

PO Box 2008
RMH Post Office
PARKVILLE, VIC., 3050
Country 8604 0
Australia
Phone 8604 0
+61 (3)9342 4584
Fax 8604 0
Email 8604 0
lara.lipton@mh.org.au

No information has been provided regarding IPD availability
Summary results
No Results