Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000519459
Ethics application status
Approved
Date submitted
14/04/2016
Date registered
21/04/2016
Date last updated
24/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Biomarkers in Pancreatic Cancer
Scientific title
Assessing Predictive and Prognostic Biomarkers in Pancreatic Cancer
Secondary ID [1] 288910 0
None
Universal Trial Number (UTN)
U1111-1181-4421
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Histologically or cytologically confirmed pancreatic cancer 298303 0
Condition category
Condition code
Cancer 298429 298429 0 0
Pancreatic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Potential subjects with pancreatic cancer may be identified at pre-admission or outpatient clinic by a clinician or VCB research coordinator, and if consent is obtained tissue, blood and/or urine sample will be collected. All patients will be treated as per standard of care. The only procedure beyond standard of care is the collection of tissue, blood and/or urine samples.

Blood and/or urine samples will be collected at the time of other standard-care assessments (such as CEA) to minimise/eliminate the need for additional venipunctures.

Blood (upto 60 ml) and urine (upto 60 ml) will be collected for research purposes on the following occasions:

1. Before and after surgical removal of pancreatic cancer (if applicable)
2. Before and after any chemotherapy regimen (if applicable)
3. Every 6 months while you are on active surveillance (if applicable)

Archival tissue specimens will be requested for each patient after enrolment. Where possible, current biopsy specimens (fresh tissue) will be collected by either Victorian Cancer Biobank or local pathology laboratories at the time of standard of care procedures,

Follow up will occur until the end of active surveillance, death or 5 years post enrolment, whichever occurs first.
Intervention code [1] 294424 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297996 0
To explore and validate novel prognostic and predictive biomarkers in pancreatic cancer.

This will be achieved using molecular analyses to identify changes in gene/ protein expression, identify mutations, or amplifications of genes that may be important in pancreatic cancer tumour prognosis and response to therapy.

Some examples of molecular techniques that may be used include:
1. Immunohistochemistry to identify expression of proteins.
2. Western blot analysis for phosphorylation status.
3. Multiplexed microarrays, used to determine relative expression changes
4. Quantitative PCR, used to test for RNA, microRNA expression and measure copy numbers of genes and determine relative expression changes
5. Next generation sequencing, used to determine mutations present in pancreatic cancer
Timepoint [1] 297996 0
Enrolled patients will undergo collection of clinical data and archival or fresh tumour specimens as part of routine clinical management, with all patients will be treated as per standard of care.

When applicable, archival tissue samples from the primary pancreatic cancer, matched normal pancreas tissue and/or resected metastases will be obtained, upon enrolment. to study. Where possible, current biopsy specimens (fresh tissue) will be collected by either Victorian Cancer Biobank or local pathology laboratories at the time of standard of care procedures.

Patients that consent to the “liquid biopsy” (blood and urine collection) sub-study will undergo collection of blood/plasma and urine at the beginning and during each systemic therapy. Blood (upto 60 ml) and urine (upto 60 ml) will be collected for research purposes on the following occasions:

1. Before and after surgical removal of pancreatic cancer (if applicable)
2. Before and after any chemotherapy regimen (if applicable)
3. Every 6 months while you are on active surveillance (if applicable)

Follow up will occur until the end of active surveillance, death or 5 years post enrolment, whichever occurs first.
Primary outcome [2] 297997 0
To explore and validate novel diagnostic and monitoring methods in pancreatic cancer.

This will be achieved using molecular analyses to identify changes in gene/ protein expression, identify mutations, or amplifications of genes that may be important in pancreatic cancer tumour prognosis and response to therapy.

Some examples of molecular techniques that may be used include:
1. Immunohistochemistry to identify expression of proteins.
2. Western blot analysis for phosphorylation status.
3. Multiplexed microarrays, used to determine relative expression changes
4. Quantitative PCR, used to test for RNA, microRNA expression and measure copy numbers of genes and determine relative expression changes
5. Next generation sequencing, used to determine mutations present in pancreatic cancer
Timepoint [2] 297997 0
Enrolled patients will undergo collection of clinical data and archival or fresh tumour specimens as part of routine clinical management, with all patients will be treated as per standard of care.

When applicable, archival tissue samples from the primary pancreatic cancer, matched normal pancreas tissue and/or resected metastases will be obtained, upon enrolment. to study. Where possible, current biopsy specimens (fresh tissue) will be collected by either Victorian Cancer Biobank or local pathology laboratories at the time of standard of care procedures.

Patients that consent to the “liquid biopsy” (blood and urine collection) sub-study will undergo collection of blood/plasma and urine at the beginning and during each systemic therapy. Blood (upto 60 ml) and urine (upto 60 ml) will be collected for research purposes on the following occasions:

1. Before and after surgical removal of pancreatic cancer (if applicable)
2. Before and after any chemotherapy regimen (if applicable)
3. Every 6 months while you are on active surveillance (if applicable)

Follow up will occur until the end of active surveillance, death or 5 years post enrolment, whichever occurs first.
Primary outcome [3] 297998 0
To explore how novel biomarkers can improve development of new drugs and/or combinations of drugs to treat pancreatic cancer.

This will be achieved using molecular analyses to identify changes in gene/ protein expression, identify mutations, or amplifications of genes that may be important in pancreatic cancer tumour prognosis and response to therapy.

Some examples of molecular techniques that may be used include:
1. Immunohistochemistry to identify expression of proteins.
2. Western blot analysis for phosphorylation status.
3. Multiplexed microarrays, used to determine relative expression changes
4. Quantitative PCR, used to test for RNA, microRNA expression and measure copy numbers of genes and determine relative expression changes
5. Next generation sequencing, used to determine mutations present in pancreatic cancer
Timepoint [3] 297998 0
Enrolled patients will undergo collection of clinical data and archival or fresh tumour specimens as part of routine clinical management, with all patients will be treated as per standard of care.

When applicable, archival tissue samples from the primary pancreatic cancer, matched normal pancreas tissue and/or resected metastases will be obtained, upon enrolment. to study. Where possible, current biopsy specimens (fresh tissue) will be collected by either Victorian Cancer Biobank or local pathology laboratories at the time of standard of care procedures.

Patients that consent to the “liquid biopsy” (blood and urine collection) sub-study will undergo collection of blood/plasma and urine at the beginning and during each systemic therapy. Blood (upto 60 ml) and urine (upto 60 ml) will be collected for research purposes on the following occasions:

1. Before and after surgical removal of pancreatic cancer (if applicable)
2. Before and after any chemotherapy regimen (if applicable)
3. Every 6 months while you are on active surveillance (if applicable)

Follow up will occur until the end of active surveillance, death or 5 years post enrolment, whichever occurs first.
Secondary outcome [1] 322860 0
To explore the correlation between novel tissue and blood-based biomarker and recurrence and survival outcomes in pancreatic cancer, i.e. the prognostic impact of the biomarker.

Correlation between fresh primary tumour specimen and blood biomarkers with recurrence and survival as assessed by data linkage to clinical data.
Timepoint [1] 322860 0
Enrolled patients will undergo collection of clinical data and archival or fresh tumour specimens as part of routine clinical management, with all patients will be treated as per standard of care.

When applicable, archival tissue samples from the primary pancreatic cancer, matched normal pancreas tissue and/or resected metastases will be obtained, upon enrolment. to study. Where possible, current biopsy specimens (fresh tissue) will be collected by either Victorian Cancer Biobank or local pathology laboratories at the time of standard of care procedures.

Patients that consent to the “liquid biopsy” (blood and urine collection) sub-study will undergo collection of blood/plasma and urine at the beginning and during each systemic therapy. Blood (upto 60 ml) and urine (upto 60 ml) will be collected for research purposes on the following occasions:

1. Before and after surgical removal of pancreatic cancer (if applicable)
2. Before and after any chemotherapy regimen (if applicable)
3. Every 6 months while you are on active surveillance (if applicable)

Follow up will occur until the end of active surveillance, death or 5 years post enrolment, whichever occurs first.
Secondary outcome [2] 322861 0
To correlate changes in tissue and blood-based biomarkers with those detected in primary and/or metastatic tissue from the same patient
Timepoint [2] 322861 0
Enrolled patients will undergo collection of clinical data and archival or fresh tumour specimens as part of routine clinical management, with all patients will be treated as per standard of care.

When applicable, archival tissue samples from the primary pancreatic cancer, matched normal pancreas tissue and/or resected metastases will be obtained, upon enrolment. to study. Where possible, current biopsy specimens (fresh tissue) will be collected by either Victorian Cancer Biobank or local pathology laboratories at the time of standard of care procedures.

Patients that consent to the “liquid biopsy” (blood and urine collection) sub-study will undergo collection of blood/plasma and urine at the beginning and during each systemic therapy. Blood (upto 60 ml) and urine (upto 60 ml) will be collected for research purposes on the following occasions:

1. Before and after surgical removal of pancreatic cancer (if applicable)
2. Before and after any chemotherapy regimen (if applicable)
3. Every 6 months while you are on active surveillance (if applicable)

Follow up will occur until the end of active surveillance, death or 5 years post enrolment, whichever occurs first.
Secondary outcome [3] 322862 0
To determine if circulating tumour DNA can be used in the diagnosis of pancreatic cancer and in the monitoring of patient response.

This will be achieved by correlation of ctDNA assay results from blood sample analyses with gold standard diagnostic marker (CA 19-9), and with patient response to treatment, as assessed by data linkage to clinical data.
Timepoint [3] 322862 0
Enrolled patients will undergo collection of clinical data and archival or fresh tumour specimens as part of routine clinical management, with all patients will be treated as per standard of care.

When applicable, archival tissue samples from the primary pancreatic cancer, matched normal pancreas tissue and/or resected metastases will be obtained, upon enrolment. to study. Where possible, current biopsy specimens (fresh tissue) will be collected by either Victorian Cancer Biobank or local pathology laboratories at the time of standard of care procedures.

Patients that consent to the “liquid biopsy” (blood and urine collection) sub-study will undergo collection of blood/plasma and urine at the beginning and during each systemic therapy. Blood (upto 60 ml) and urine (upto 60 ml) will be collected for research purposes on the following occasions:

1. Before and after surgical removal of pancreatic cancer (if applicable)
2. Before and after any chemotherapy regimen (if applicable)
3. Every 6 months while you are on active surveillance (if applicable)

Follow up will occur until the end of active surveillance, death or 5 years post enrolment, whichever occurs first.
Secondary outcome [4] 322863 0
To explore the correlation between tissue and blood-based biomarker and clinical outcomes (e.g. response rate, progression-free survival and overall survival) according to treatment received, i.e. can certain biomarkers predict for therapy response, as assessed by data linkage to clinical data.
Timepoint [4] 322863 0
Enrolled patients will undergo collection of clinical data and archival or fresh tumour specimens as part of routine clinical management, with all patients will be treated as per standard of care.

When applicable, archival tissue samples from the primary pancreatic cancer, matched normal pancreas tissue and/or resected metastases will be obtained, upon enrolment. to study. Where possible, current biopsy specimens (fresh tissue) will be collected by either Victorian Cancer Biobank or local pathology laboratories at the time of standard of care procedures.

Patients that consent to the “liquid biopsy” (blood and urine collection) sub-study will undergo collection of blood/plasma and urine at the beginning and during each systemic therapy. Blood (upto 60 ml) and urine (upto 60 ml) will be collected for research purposes on the following occasions:

1. Before and after surgical removal of pancreatic cancer (if applicable)
2. Before and after any chemotherapy regimen (if applicable)
3. Every 6 months while you are on active surveillance (if applicable)

Follow up will occur until the end of active surveillance, death or 5 years post enrolment, whichever occurs first.
Secondary outcome [5] 322864 0
To assess the dynamic changes in tissue and blood-based biomarkers in response to cytotoxic chemotherapies, and/or molecularly targeted therapies, and/or biologic agents
Timepoint [5] 322864 0
Enrolled patients will undergo collection of clinical data and archival or fresh tumour specimens as part of routine clinical management, with all patients will be treated as per standard of care.

When applicable, archival tissue samples from the primary pancreatic cancer, matched normal pancreas tissue and/or resected metastases will be obtained, upon enrolment. to study. Where possible, current biopsy specimens (fresh tissue) will be collected by either Victorian Cancer Biobank or local pathology laboratories at the time of standard of care procedures.

Patients that consent to the “liquid biopsy” (blood and urine collection) sub-study will undergo collection of blood/plasma and urine at the beginning and during each systemic therapy. Blood (upto 60 ml) and urine (upto 60 ml) will be collected for research purposes on the following occasions:

1. Before and after surgical removal of pancreatic cancer (if applicable)
2. Before and after any chemotherapy regimen (if applicable)
3. Every 6 months while you are on active surveillance (if applicable)

Follow up will occur until the end of active surveillance, death or 5 years post enrolment, whichever occurs first.
Secondary outcome [6] 322865 0
To determine if early changes in blood-based biomarkers are a sensitive and specific predictor of response or resistance to systemic chemotherapy and/or biologic agents compared to CT imaging.
Timepoint [6] 322865 0
Enrolled patients will undergo collection of clinical data and archival or fresh tumour specimens as part of routine clinical management, with all patients will be treated as per standard of care.

When applicable, archival tissue samples from the primary pancreatic cancer, matched normal pancreas tissue and/or resected metastases will be obtained, upon enrolment. to study. Where possible, current biopsy specimens (fresh tissue) will be collected by either Victorian Cancer Biobank or local pathology laboratories at the time of standard of care procedures.

Patients that consent to the “liquid biopsy” (blood and urine collection) sub-study will undergo collection of blood/plasma and urine at the beginning and during each systemic therapy. Blood (upto 60 ml) and urine (upto 60 ml) will be collected for research purposes on the following occasions:

1. Before and after surgical removal of pancreatic cancer (if applicable)
2. Before and after any chemotherapy regimen (if applicable)
3. Every 6 months while you are on active surveillance (if applicable)

Follow up will occur until the end of active surveillance, death or 5 years post enrolment, whichever occurs first.
Secondary outcome [7] 322866 0
To identify new drugs and/or combinations of drugs that target multiple cascades within a patient’s pancreatic tumour, in order to design combination treatment strategies that will overcome the complication of numerous genetic mutations. This will be achieved by review of blood and urine biomarker changes over time and in response to different treatment types.
Timepoint [7] 322866 0
Enrolled patients will undergo collection of clinical data and archival or fresh tumour specimens as part of routine clinical management, with all patients will be treated as per standard of care.

When applicable, archival tissue samples from the primary pancreatic cancer, matched normal pancreas tissue and/or resected metastases will be obtained, upon enrolment. to study. Where possible, current biopsy specimens (fresh tissue) will be collected by either Victorian Cancer Biobank or local pathology laboratories at the time of standard of care procedures.

Patients that consent to the “liquid biopsy” (blood and urine collection) sub-study will undergo collection of blood/plasma and urine at the beginning and during each systemic therapy. Blood (upto 60 ml) and urine (upto 60 ml) will be collected for research purposes on the following occasions:

1. Before and after surgical removal of pancreatic cancer (if applicable)
2. Before and after any chemotherapy regimen (if applicable)
3. Every 6 months while you are on active surveillance (if applicable)

Follow up will occur until the end of active surveillance, death or 5 years post enrolment, whichever occurs first.

Eligibility
Key inclusion criteria
1. Male and female
2. At least 18 years of age
3. Patients with histologically or cytologically confirmed pancreatic cancer.
4. Able to provide archival tumour specimen for molecular analysis
5. Accessible for follow up and data collection
6. Able and willing to provide informed consent for any blood and urine collection above standard of care. Able to provide written, voluntary and informed consent for blood and/or urine collection
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. No archival tissue specimen available for molecular analysis
2. Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the tissue collection protocol
3. Females who are pregnant

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This protocol aims to identify prognostic and predictive biomarkers. The proposed study size includes 500 patients. Assuming alpha of 0.05, the number of patients enrolled into this protocol is sufficient to identify a biomarker that predicts for recurrence in greater than 40% of patients, with power of 0.8.

Descriptive statistics will be used to analyse data arising directly from this protocol study. The Kaplan-Meier method and the Mantel-Cox log-rank test will be used for survival analyses. Proportions will be compared using the Chi square method or Fisher’s exact test. For all analyses, two-sided p values of < 0.05 were considered significant. Multivariate survival analyses will use the Cox Proportional Hazards method.

Using multivariate analyses will allow for detection of prognostic biomarkers while minimising impact of selection and information biases. Selection bias for predictive biomarkers are minimised by the fact that only patients who have received each particular treatment will be included in the analysis, and in Australia, each treatment is only available at certain points during a patient’s disease course.

Further statistical methodology and calculations will be provided for each specific project that wishes to analyse aspects of this data and tissue set. The results of the various assays will be collated and analysed. The results of the biomarker studies will be examined statistically to determine the specificity and sensitivity of single or any combination of markers in detecting the presence of Pancreatic ductal adenocarcinoma (PDAC), predicting recurrence risk and response/resistance to treatment. As these studies are exploratory and observational with no treatment intervention, no formal statistical hypothesis will be tested.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2017
Actual
Date of last participant enrolment
Anticipated
1/05/2026
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5623 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 5625 0
Western Hospital - Footscray
Recruitment hospital [3] 5626 0
Sunshine Hospital - St Albans
Recruitment hospital [4] 5627 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 13068 0
3050 - Royal Melbourne Hospital
Recruitment postcode(s) [2] 13071 0
3011 - Footscray
Recruitment postcode(s) [3] 13072 0
3021 - St Albans
Recruitment postcode(s) [4] 13073 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 293359 0
Other Collaborative groups
Name [1] 293359 0
The Walter and Eliza Hall Institute of Medical Research
Country [1] 293359 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Walter and Eliza Hall Institute of Medical Research
Address
1G Royal Pde
Parkville
Vic 3052
Country
Australia
Secondary sponsor category [1] 292185 0
None
Name [1] 292185 0
Address [1] 292185 0
Country [1] 292185 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294826 0
Melbourne Health HREC
Ethics committee address [1] 294826 0
Ethics committee country [1] 294826 0
Date submitted for ethics approval [1] 294826 0
09/03/2016
Approval date [1] 294826 0
23/03/2016
Ethics approval number [1] 294826 0
HREC/16/MH/30

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

Contacts
Principal investigator
Name 64846 0
Dr Belinda Lee
Address 64846 0
Gibbs Lab
Systems Biology and Personalised Medicine Division
The Walter and Eliza Hall Institute of Medical Research
1G Royal Pde
Parkville
VIC
3052
Country 64846 0
Australia
Phone 64846 0
+61 3 93452893
Fax 64846 0
Email 64846 0
belinda.lee@mh.org.au
Contact person for public queries
Name 64847 0
Siavash Foroughi
Address 64847 0
Gibbs Lab
Systems Biology and Personalised Medicine Division
The Walter and Eliza Hall Institute of Medical Research
1G Royal Pde
Parkville
VIC
3052
Country 64847 0
Australia
Phone 64847 0
+61 3 9345 2894
Fax 64847 0
Email 64847 0
siavash.foroughi@mh.org.au
Contact person for scientific queries
Name 64848 0
Belinda Lee
Address 64848 0
Gibbs Lab
Systems Biology and Personalised Medicine Division
The Walter and Eliza Hall Institute of Medical Research
1G Royal Pde
Parkville
VIC
3052
Country 64848 0
Australia
Phone 64848 0
+61 3 93452893
Fax 64848 0
Email 64848 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
No additional documents have been identified.