Gene Expression in Pancreatic Cancer (NEOPANC-01)
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|ClinicalTrials.gov Identifier: NCT03531125|
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : October 24, 2019
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.
|Condition or disease||Intervention/treatment|
|Pancreatic Cancer||Procedure: Endoscopic Ultrasound Procedure: Pancreaticoduodenectomy|
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||A Phase 0, Pre-operative, Window-of-opportunity Study to Assess Gene Expression in Patients With Resectable, Locally Advanced, or Metastatic Pancreatic Cancer (NEOPANC-01)|
|Actual Study Start Date :||July 2, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
- Procedure: Endoscopic Ultrasound
Endoscopic ultrasound for tumour biopsy collection
- Procedure: Pancreaticoduodenectomy
Surgery to remove pancreatic tumour
- 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 EUS [ Time Frame: Up to 6 weeks - Time between Endoscopic Ultrasound and surgery or follow up EUS ]
- 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 analysis [ Time Frame: Up to 6 weeks - Time between Endoscopic Ultrasound and surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531125
|Contact: Steven Davis||01865 617087||octo-NEOPANC@oncology.ox.ac.uk|
|Oxford University Hospitals NHS Foundation Trust||Recruiting|
|Oxford, United Kingdom|