Porto-Venous Radiomics in Pancreatic Cancer

NCT05700110 | Unknown

• 1 other identifier: CCR5615
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  12 months from recruitment of first patient

Interventions

Non-Interventional OTHER

Non-interventional

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

The Royal Marsden NHS Foundation Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 26, 2023
• Study Start: May 5, 2022
• Primary Completion: May 5, 2023
• Study Completion: May 5, 2024
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)