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Gene Expression in Pancreatic Cancer (NEOPANC-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03531125
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : October 24, 2019
Information provided by (Responsible Party):
University of Oxford

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Intervention Details:
  • Procedure: Endoscopic Ultrasound
    Endoscopic ultrasound for tumour biopsy collection
  • Procedure: Pancreaticoduodenectomy
    Surgery to remove pancreatic tumour

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Description:
Tumour biopsy

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Secondary care

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03531125

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Contact: Steven Davis 01865 617087

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United Kingdom
Oxford University Hospitals NHS Foundation Trust Recruiting
Oxford, United Kingdom
Sponsors and Collaborators
University of Oxford

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Responsible Party: University of Oxford Identifier: NCT03531125    
Other Study ID Numbers: OCTO_087
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases