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Clinical Trial Record

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Gene Expression in Pancreatic Cancer

2018-07-02

2020-02-28

2020-02-28

9

Study Overview

Gene Expression in Pancreatic Cancer

Pancreatic cancer is a lethal disease. The 1-year and 5-year survival rate is approximately 20% and <5% respectively. The treatment options available are limited. Only around 10-20% of patients present early enough to undergo surgical resection. Furthermore, chemotherapy for more advanced pancreatic cancer leads to limited survival benefit and can cause significant side effects. One of the main obstacles to developing new treatments for pancreatic cancer is the limited understanding of how pancreatic cancer cells change/evolve/adapt following treatment. This study is a pilot study to assess whether the investigators can track gene expression (using a technique called RNA sequencing) in pancreatic cancer cells between two separate time points. Investigators intend to take a tissue sample (biopsy) of the cancer using endoscopy ultrasound (EUS) and compare it with samples taken either at the time of surgery in those patients with resectable disease or follow-up EUS derived biopsies in irresectable cancers. The interval between endoscopy and follow-up EUS or surgery will be approximately 2 to 3 weeks and reflects the standard period of time that patients wait from the time point at which the cancer is deemed to be operable (in the multi-disciplinary team meeting) to the actual operation. If the investigators find that the samples (biopsies) taken at EUS and at surgery or follow-up EUS are comparable they plan to develop future clinical trials of similar design but with the addition of drug therapy. The investigators will use RNA sequencing to interrogate the effects of novel cancer drugs on gene expression within the tumour. This will give them information on how to select patients for therapy, how resistance develops to these treatments, and allow the investigators to better understand what treatments can be combined on a rational basis. However, prior to undertaking such studies it is important to understand how much variability there is in gene expression between sampling at 2 different time points at which two different techniques are used.

N/A

  • Pancreatic Cancer
  • PROCEDURE: Endoscopic Ultrasound
  • PROCEDURE: Pancreaticoduodenectomy
  • OCTO_087

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2018-05-08  

N/A  

2020-03-23  

2018-05-08  

N/A  

2020-03-25  

2018-05-21  

N/A  

2019-04  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/ArmIntervention/Treatment
Primary Outcome MeasuresMeasure DescriptionTime Frame
Comparison of whole transcriptome RNA sequencing of EUS derived pre-operative sample and whole transcriptome RNA sequencing of biopsies either taken from the pancreatic cancer during resection or repeat biopsy using EUSUp to 6 weeks - Time between Endoscopic Ultrasound and surgery or follow up EUS
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Percentage and number of patients that undergo EUS and follow up EUS or surgery that have a) histopathological evidence of adenocarcinoma in their biopsy and surgical samples, and b) of suitable RNA quality for analysisUp to 6 weeks - Time between Endoscopic Ultrasound and surgery

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion criteria:
    1. Male or female, aged 18 years or above 2. Patients with pancreatic cancer planned for surgical resection, or patients with locally advanced or metastatic pancreatic cancer 3. For patients planned for resection the tumour must be within the head of the pancreas such that the EUS biopsy sites and needle track can be resected surgically 4. Adequate blood clotting parameters in order to undergo an EUS with biopsies, evidenced by the following:
    1. Platelet count ≥ 75 x 109L 2. International normalised ratio (INR) ≤ 1.5 5. Patients have given written informed consent and are willing and able to comply with the scheduled visits, laboratory tests and study procedures including endoscopy (e.g. patients able to lie flat without being breathless and have no evidence of oesophageal stricture)
    Exclusion criteria:
    1. Previous histologically or cytologically confirmed pancreatic tumour that is not adenocarcinoma 2. Other psychological, social or medical condition, physical examination finding(s) or a laboratory abnormality that the investigator(s) considers would make the patient a poor study candidate or could interfere with protocol compliance or the interpretation of study results 3. Positive screening pregnancy test if woman of child bearing potential

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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