Biomarkers in Pancreatic Cancer

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000519459
• Date of registration: 21/04/2016
• Prospective Registration: Yes
• Primary sponsor: The Walter and Eliza Hall Institute of Medical Research
• Public title: Biomarkers in Pancreatic Cancer
• Scientific title: Assessing Predictive and Prognostic Biomarkers in Pancreatic Cancer
• Date of first enrolment: 01/06/2017
• Target sample size: 500
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12616000519459.aspx
• Study type: Observational
• Study design: Purpose: Screening;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Mr Siavash Foroughi

• Name: Dr Belinda Lee

Key inclusion & exclusion criteria

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
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

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Pancreatic

Histologically or cytologically confirmed pancreatic cancer;
Histologically or cytologically confirmed pancreatic cancer

Intervention(s)

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.

Primary Outcome(s)

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[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.]

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[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.]

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[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(s)

To correlate changes in tissue and blood-based biomarkers with those detected in primary and/or metastatic tissue from the same patient[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.]

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.[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.]

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.[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.]

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.[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.]

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.[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.]

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.[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.]

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[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 ID(s)

None

Source(s) of Monetary Support

The Walter and Eliza Hall Institute of Medical Research

Ethics review

Status: Approved
Approval date:
Contact:

Melbourne Health HREC