Pancreatic CancerNCT05700110
Porto-Venous Radiomics in Pancreatic Cancer
An observational study of Pancreatic Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Multi-centre Retrospective Observational Cohort study of patients who underwent pancreaticoduodenectomy from 01/01/2005 to 01/02/2022 with histologically confirmed pancreatic head malignancy Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Non-Interventional
- How many people
- 800 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 May 2022to 5 May 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients on locally maintained patient databases recorded as having undergone a pancreaticoduodenectomy or Whipple's surgery on or after 01/01/2005 will be screened by the local clinical team for eligibility.
Who may be able to join
- Patients who underwent pancreaticoduodenectomy/Whipple's surgery for pancreatic head malignancy between 01/01/2005 and 01/02/2022.
- Pre-operative Computed Tomographic images within 90 days prior to surgical resection.
- Post-operative histological confirmation of pancreatic ductal adenocarcinoma (PDAC), ampullary adenocarcinoma (AA), distal bile duct carcinoma (DBC), pancreatic neuroendocrine tumours (NET/NEC), duodenal adenocarcinoma (DA) or duodenal gastro-intestinal stromal tumours (GIST).
Who cannot join
- Postoperative surgical histology confirming benign pathology, metastatic disease or invasive malignancy arising from sites other than duodenum, pancreatic head or distal common bile duct.
- Patients who underwent distal pancreatectomy or total pancreatectomy as their primary surgical procedure.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Marsden NHS Foundation Trust
London
Mark Brandon-Grove, 02031865416, Mark.Brandon-Grove@rmh.nhs.uk
Ricky Mr Bhogal
About this study
Official title: Porto-venous Radiomics in Pancreatic Cancer: A Multi-centre Retrospective Cohort Study Investigating the Use of Pre-operative CT Radiomic Features to Predict Surgical Resection Margin in Pancreatic Head Malignancy
Multi-centre Retrospective Observational Cohort study of patients who underwent pancreaticoduodenectomy from 01/01/2005 to 01/02/2022 with histologically confirmed pancreatic head malignancy
Read the detailed description
Pancreatic cancers are often inoperable at diagnosis, with only 13-22% of patients being suitable for surgical resection.1 Surgery is the only curative therapeutic option for pancreatic cancer and higher rates of long-term patient survival following surgery are seen in patients where the tumour is completely removed (termed R0 resection). However a majority of those patients who undergo surgery will develop tumour recurrence at the primary surgical site or a distant location. The likelihood of cancer recurrence following surgery increases when there is involvement of major blood vessels that lie adjacent to the pancreas. This involvement is often microscopic in nature and only detected after surgery when the surgical specimen is examined microscopically (termed R1 resection). Pre-operative cross-sectional imaging (usually Computed Tomography (CT) is the standard tool used to assess the risk of R1 resection prior to pancreatic cancer. However this approach significantly overestimates the number of patients with a resectable tumour as a significant proportion ultimately have an R1 resection after surgery. If there is felt to be an increased risk of R1 resection prior to surgery the patient can be offered oncological treatment prior to surgery to improve the rates of R0 resection that in turn improve long-term patient survival.
The emerging field of Radiomics offers the opportunity to stratify patients undergoing pancreatic cancer surgery into those at risk of R1 resection prior to surgery. Radiomics has emerged as a valuable adjunct to medical decision making over the past 10 years. The basic premise is to extract and analyse large amounts of information not usually visible to the human eye from medical images, and it is increasingly being used in the field of cancer diagnostics. The aim of this study is to employ 3D radiomic analyses to pre-operative CT scan images for cases of pancreatic head cancer that underwent surgical resection, to determine whether this information could be used to predict R0 and R1 resection margins pre-operatively.
- Conditions
- Pancreatic Cancer
- Being tested
- Non-Interventional
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-interventional
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop a Radiomics model based on pre-operative CT porto-venous phase imaging that accurately predicts Resection Margin status in pancreatic head malignancy
R classification of resection margin status on post-operative histological analysis as per the Royal College of Pathologists classification
Measured: 12 months from recruitment of first patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start5 May 2022
- Primary completion5 May 2023 (estimated)
- Study completion5 May 2024 (estimated)
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 Royal Marsden NHS Foundation TrustThe 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
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700110
- Sponsor's protocol ID
- CCR5615
- Status last verified
- Jan 2023
- First submitted
- 17 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Porto-venous Radiomics in Pancreatic Cancer: A Multi-centre Retrospective Cohort Study Investigating the Use of Pre-operative CT Radiomic Features to Predict Surgical Resection Margin in Pancreatic Head Malignancy
- ClinicalTrials.gov ID
- NCT05700110
- Acronym / sponsor ID
- CCR5615
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 5 May 2023 (estimated)
- Study completion
- 5 May 2024 (estimated)
- First posted
- 26 Jan 2023 (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.
Multi-centre Retrospective Observational Cohort study of patients who underwent pancreaticoduodenectomy from 01/01/2005 to 01/02/2022 with histologically confirmed pancreatic head malignancy
Detailed description
Pancreatic cancers are often inoperable at diagnosis, with only 13-22% of patients being suitable for surgical resection.1 Surgery is the only curative therapeutic option for pancreatic cancer and higher rates of long-term patient survival following surgery are seen in patients where the tumour is completely removed (termed R0 resection). However a majority of those patients who undergo surgery will develop tumour recurrence at the primary surgical site or a distant location. The likelihood of cancer recurrence following surgery increases when there is involvement of major blood vessels that lie adjacent to the pancreas. This involvement is often microscopic in nature and only detected after surgery when the surgical specimen is examined microscopically (termed R1 resection). Pre-operative cross-sectional imaging (usually Computed Tomography (CT) is the standard tool used to assess the risk of R1 resection prior to pancreatic cancer. However this approach significantly overestimates the number of patients with a resectable tumour as a significant proportion ultimately have an R1 resection after surgery. If there is felt to be an increased risk of R1 resection prior to surgery the patient can be offered oncological treatment prior to surgery to improve the rates of R0 resection that in turn improve long-term patient survival.
The emerging field of Radiomics offers the opportunity to stratify patients undergoing pancreatic cancer surgery into those at risk of R1 resection prior to surgery. Radiomics has emerged as a valuable adjunct to medical decision making over the past 10 years. The basic premise is to extract and analyse large amounts of information not usually visible to the human eye from medical images, and it is increasingly being used in the field of cancer diagnostics. The aim of this study is to employ 3D radiomic analyses to pre-operative CT scan images for cases of pancreatic head cancer that underwent surgical resection, to determine whether this information could be used to predict R0 and R1 resection margins pre-operatively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients on locally maintained patient databases recorded as having undergone a pancreaticoduodenectomy or Whipple's surgery on or after 01/01/2005 will be screened by the local clinical team for eligibility.
Key inclusion criteria (3 listed)
- Patients who underwent pancreaticoduodenectomy/Whipple's surgery for pancreatic head malignancy between 01/01/2005 and 01/02/2022.
- Pre-operative Computed Tomographic images within 90 days prior to surgical resection.
- Post-operative histological confirmation of pancreatic ductal adenocarcinoma (PDAC), ampullary adenocarcinoma (AA), distal bile duct carcinoma (DBC), pancreatic neuroendocrine tumours (NET/NEC), duodenal adenocarcinoma (DA) or duodenal gastro-intestinal stromal tumours (GIST).
Key exclusion criteria (2 listed)
- Postoperative surgical histology confirming benign pathology, metastatic disease or invasive malignancy arising from sites other than duodenum, pancreatic head or distal common bile duct.
- Patients who underwent distal pancreatectomy or total pancreatectomy as their primary surgical procedure.
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 |
|---|---|---|
| Non-InterventionalNon-interventional | Other | – |
Primary outcome
To develop a Radiomics model based on pre-operative CT porto-venous phase imaging that accurately predicts Resection Margin status in pancreatic head malignancy
Time frame: 12 months from recruitment of first patient
R classification of resection margin status on post-operative histological analysis as per the Royal College of Pathologists classification
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: No
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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 Royal Marsden NHS Foundation Trust
London, United Kingdom
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 Royal Marsden NHS Foundation Trust 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To develop a Radiomics model based on pre-operative CT porto-venous phase imaging that accurately predicts Resection Margin status in pancreatic head malignancy (time frame: 12 months from recruitment of first patient). 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 26 Jan 2023.