Title

NEOPANC-01

Chief Investigator: 
Simon Lord

Trial Sponsor: University of Oxford

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

Design: This phase 0, window-of-opportunity study aims to assess whether we can track gene expression (using 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.

If we find that the 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.

Study Status: Open

Site: Churchill Hospital, Oxford University Hospital Trust

Target Recruitment: 10 patients

Inclusion Criteria:

  1. Male or female, aged 18 years or above

  2. Patients with pancreatic cancer within the head of the pancreas such that the EUS biopsy sites and needle track can be resected surgically

  3. Planned resection of pancreatic cancer

  4. Adequate blood clotting parameters in order to undergo an EUS with biopsies, evidenced by the following.

    1. Platelet count ≥ 75 x 109/L

    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

Study Flow Chart:

Primary outcome measure:

Comparison of whole transcriptome RNA sequencing of EUS derived pre-operative biopsies and whole transcriptome RNA sequencing of biopsies taken from the pancreatic cancer during resection.

Secondary outcome measures:

Percentage and number of patients that undergo EUS and surgery that have a) histopathological evidence of adenocarcinoma in their biopsy and surgical samples, and b) of suitable RNA quality for analysis.

Contact details:

NEOPANC-01 Trial Office (OCTO):

UK Tel: 01865 617 087

Email: octo-neopanc@oncology.ox.ac.uk

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