A Prospective Translational Tissue Collection Study in Early and Advanced Pancreatic Ductal Adenocarcinoma and Pancreatic Neuroendocrine Tumours to Enable Further Disease Characterisation and the Development of Potential Predictive and Prognostic Biomarkers

NCT03840460 | Unknown

• 1 other identifier: CCR4753
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

There are several types of early pre-cancerous lesions found in the pancreas which have the potential to develop into pancreatic cancer. Although different patients' pancreatic cancers or pre-cancerous pancreatic lesions have many similarities we believe that subtle differences can affect how they behave and therefore influence individual patient outcomes. Many factors may account for the differences seen in pancreatic lesion behaviour, for example molecular and genetic differences (the DNA and RNA present which control how a cell grows and divides), differences in how the immune system responds to the lesion, differences in the environment immediately around the lesion in the pancreas, known as the tumour microenvironment and differences in the micro-organisms which colonize a particular patient, known as their microbiota . This project studies the molecular makeup of pancreatic lesions and their microenvironment at various stages (from pre-cancerous lesions all the way through to more advanced disease) to see if we can use this information to divide patients into different groups whose lesions may behave in similar ways. We will be trying to find out if there are molecular reasons why some patients respond to particular treatments when others do not, why some patients experience more toxicity with particular treatments and why some patients' disease behaves particularly aggressively when other patients' disease does not. We will also be investigating the particular micro-organisms colonizing individual patients to see if these impact a patient's outcome. Understanding what makes one person's pancreatic lesion behave differently to another's could lead to better treatment, where a personalized therapeutic strategy could be applied for every single patient.

Conditions

Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• to describe the incidence and distribution of biomarkers and identify molecular subtypes in a large, multi-centre, series of patients with pancreatic cancer and precursor lesions.

  Blood, urine, stool, saliva, bile and tissue samples from patients undergoing a tissue biopsy or surgery for suspected or known pancreatic cancer will be collected

  4 years

Secondary Outcomes (2)

• To describe the incidence and distribution of biomarkers and identify molecular subtypes in a large, multi-centre, population of patients with pancreatic cancer or precursor lesions.

  4 years

• To identify molecular predictors of response or toxicity to standard of care anti-cancer therapies in PDAC/PanNET.

  4 years

Other Outcomes (3)

• Depending on the number of patients assessable for each biomarker of interest and the prevalence of biomarker expression in the study population, exploratory endpoints of this study include

  4 years

• Depending on the number of patients assessable for each biomarker of interest and the prevalence of biomarker expression in the study population, exploratory endpoints of this study include

  4 years

• Depending on the number of patients assessable for each biomarker of interest and the prevalence of biomarker expression in the study population, exploratory endpoints of this study include

  4 years

Study Arms (1)

Pancreatic Cancer

Patients who are investigated for and subsequently diagnosed with early/advanced pancreatic adenocarcinoma or a precursor lesion or a pancreatic neuroendocrine tumour.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patient is ≥ 18 years of age.
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

early/advanced pancreatic adenocarcinoma or a precursor lesion or a pancreatic neuroendocrine tumour.

You may qualify if:

• Patient is being investigated or treated for pancreatic cancer or precursor lesions at The Royal Marsden Hospital and referring centres during the study period.
• Patient has a histologically/cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma, or pancreatic neuroendocrine tumour OR Patient has a tissue lesion suspicious for pancreatic cancer amenable to core needle biopsy or surgery and is clinically fit enough to undergo a tumour biopsy or surgery according to investigator assessment and local guidelines.
• Patient is ≥ 18 years of age.
• Patient can understand the patient information sheet and is able to provide written informed consent.
• Patient has sufficient tissue and/or blood and/or urine and/or stool and/or saliva sampling for analysis as per the protocol.

You may not qualify if:

• \. Patients who are not treated at all at The Royal Marsden Hospital or referring centre.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The collected blood and tissue will undergo molecular analyses, including but not limited to, miRNA analysis, DNA and RNA sequencing, nanostring, real-time PCR and immunohistochemistry. Molecular analysis data will be correlated with clinical outcome data and allow characterization of subtypes in pancreatic cancer, considering both pancreatic ductal adenocarcinoma and pancreatic neuroendocrine tumours.

Study Officials

• David Cunningham

  The Royal Marsden Hospital NHS Foundation Trust

  STUDY CHAIR

Central Study Contacts

Bijal Patel

CONTACT

02086426011; bijal.patel@rmh.nhs.uk

David Lau

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 15, 2019
• Study Start: January 10, 2019
• Primary Completion: January 10, 2023
• Study Completion: January 10, 2023
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

GB (1)