Pancreatic CancerNEOPANC-01NCT03531125
Gene Expression in Pancreatic Cancer
An observational study of Pancreatic Cancer, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Endoscopic Ultrasound and Pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jul 2018to 28 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Secondary care
Who may be able to join
- Male or female, aged 18 years or above
- Patients with pancreatic cancer planned for surgical resection, or patients with locally advanced or metastatic pancreatic cancer
- 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
- Adequate blood clotting parameters in order to undergo an EUS with biopsies, evidenced by the following:
- Platelet count ≥ 75 x 109L
- International normalised ratio (INR) ≤ 1.5
- 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)
Who cannot join
- Previous histologically or cytologically confirmed pancreatic tumour that is not adenocarcinoma
- 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
- Positive screening pregnancy test if woman of child bearing potential
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hospitals NHS Foundation Trust
Oxford
About this study
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)
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.
Read more
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Endoscopic Ultrasound, Pancreaticoduodenectomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic UltrasoundProcedure or surgery
Endoscopic ultrasound for tumour biopsy collection
PancreaticoduodenectomyProcedure or surgery
Surgery to remove pancreatic tumour
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 6 weeks - Time between Endoscopic Ultrasound and surgery or follow up EUS
Secondary outcomes (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
Measured: Up to 6 weeks - Time between Endoscopic Ultrasound and surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start2 Jul 2018
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Why it stopped: Study was closed early due to low numbers of evaluable patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531125
- Sponsor's protocol ID
- OCTO_087
- Acronym
- NEOPANC-01
- Status last verified
- Apr 2019
- First submitted
- 8 May 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03531125
- Acronym / sponsor ID
- NEOPANC-01 / OCTO_087
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was closed early due to low numbers of evaluable patients
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Secondary care
Key inclusion criteria (7 listed)
- Male or female, aged 18 years or above
- Patients with pancreatic cancer planned for surgical resection, or patients with locally advanced or metastatic pancreatic cancer
- 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
- Adequate blood clotting parameters in order to undergo an EUS with biopsies, evidenced by the following:
- 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)
Key exclusion criteria (3 listed)
- Previous histologically or cytologically confirmed pancreatic tumour that is not adenocarcinoma
- 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
- Positive screening pregnancy test if woman of child bearing potential
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic UltrasoundEndoscopic ultrasound for tumour biopsy collection | Procedure or surgery | – |
| PancreaticoduodenectomySurgery to remove pancreatic tumour | Procedure or surgery | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Study was closed early due to low numbers of evaluable patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was closed early due to low numbers of evaluable patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.