NCT03531125: NEOPANC-01

Gene Expression in Pancreatic Cancer

Terminated Last updated 25 March 2020

What this trial tests

trial testing Endoscopic Ultrasound in Pancreatic Cancer in 9 participants. Terminated before completion.

Timeline

2 July 2018

Primary endpoint
28 February 2020

28 February 2020

Quick facts

Lead sponsor	University of Oxford
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	9
Start date	2 July 2018
Primary completion	28 February 2020
Estimated completion	28 February 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

• Endoscopic Ultrasound
• Pancreaticoduodenectomy

Conditions studied

• Pancreatic Cancer — all drugs for Pancreatic Cancer →

Sponsor

University of Oxford

Who can join

18 and older, any sex, with Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Gene Therapy for Pancreatic Diseases: Current Status.
   Kamimura K, Yokoo T, Terai S. · · 2018 · cited 11× · PMID 30384450 · DOI 10.3390/ijms19113415