Gene expression in resectable pancreatic cancer

  • Research type

    Research Study

  • Full title

    A phase 0, pre-operative, window-of-opportunity study to assess gene expression in patients with resectable pancreatic cancer (NEOPANC-01)

  • IRAS ID

    222970

  • Contact name

    Simon Lord

  • Contact email

    simon.lord@oncology.ox.ac.uk

  • Sponsor organisation

    University of Oxford

  • Duration of Study in the UK

    3 years, 0 months, 0 days

  • Research summary

    Summary of Research
    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 our limited understanding of how pancreatic cancer cells change/evolve/adapt following treatment.\n\nThis study is a pilot study to assess whether we can track gene expression (using a technique called RNA sequencing) in pancreatic cancer cells between two separate time points. We intend to take a tissue sample (biopsy) of the cancer using endoscopy ultrasound (EUS) and compare it with samples taken at the time of surgery in those patients with resectable disease. The interval between endoscopy and 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.\n\nIf we find that the samples (biopsies) taken at EUS and surgery are comparable we plan to develop future clinical trials of similar design but with the addition of drug therapy. Here we will use RNA sequencing to interrogate the effects of novel cancer drugs on gene expression within the tumour. This will give us information on how to select patients for therapy, how resistance develops to these treatments, and allow us to better understand what treatments can be combined on a rational basis. However, prior to undertaking such studies it is important to understand much variability there is in gene expression between sampling at 2 different time points at which two different techniques are used.\n

    Summary of Results
    A good way to find out more about the cancer cells and how well treatment works is for your doctors to take a small piece of cancer tissue (biopsy) before and after treatment. This study collected tissue samples using a technique called an endoscopic ultrasound from people with pancreatic cancer.
    There is a new way of looking at these samples. This is called RNA sequencing. RNA stands for ribonucleic acid. RNA sequencing looks at molecules or small particles that cancer cells make. It is proving to be a useful way to understand how drugs work in cancer treatment. And work out how cancer cells become resistant to treatment.
    In pancreatic cancer, specialists don't usually take biopsies before surgery if they think they can remove the cancer with surgery. But a newer technique called an endoscopic ultrasound means it is now easier to take samples. To have this test your doctor passes a small flexible tube through your mouth and down your throat (an endoscopy). On the end of the tube is an ultrasound probe.
    This is routine in most hospitals. But researchers had not done a study looking at EUS to collect samples for RNA sequencing in pancreatic cancer. Researchers in Oxford think it is important to check the samples they collect are satisfactory. They want to look at differences in RNA sequencing samples taken:
    • Before surgery
    • At surgery or follow up
    However, due to the low number of evaluable patients we were unable to make an assessment as to whether the samples were satisfactory. As a result, the study was terminated early. Only 2/9 patients had evidence of cancer in both sets of samples collected at EUS and repeat EUS or surgery. Given this low number of evaluable patients, the decision was made to not proceed with RNA sequencing.

  • REC name

    South Central - Oxford A Research Ethics Committee

  • REC reference

    18/SC/0130

  • Date of REC Opinion

    20 Apr 2018

  • REC opinion

    Favourable Opinion