Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04597710
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-24
First Post:
2020-10-13
Brief Title:
Precision Medicine for Liver Tumours With Quantitative Magnetic Resonance Imaging and Whole Genome Sequencing
Sponsor:
Perspectum
Organization:
Perspectum
Study Overview
Official Title:
Precision Medicine for Liver Tumours With Quantitative Magnetic Resonance Imaging and Whole Genome Sequencing
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Precision1
Brief Summary:
This will be a prospective observational cohort study to determine the impact of integrated diagnostics using quantitative magnetic resonance imaging whole genome sequencing and digital pathology on intended patient management for liver cancer patients referred for liver resection
Participants with primary or secondary liver cancer will be recruited from Hampshire Hospitals NHS Foundation Trust in Basingstoke or Oxford University Hospitals NHSFoundation Trust in Oxford The incidence of treatable liver tumours is on the rise globally driven by obesity viral hepatitis and metastases from colorectal cancers Survival rates can be improved with optimised allocation of treatment options including surgical resection radiofrequency ablation embolisation chemotherapy and targeted molecular therapies including immunotherapy
The key motivation of this study is to help patients access the most suitable treatment combinations based on integrating clinical radiological and genomic data A similar integrated approach integrating radiology and pathology has been shown to improve outcomes in breast cancer care Detailed pathologic analysis of the surgical specimen from breast carcinoma biopsy provides valuable feedback to the radiologist establishes the completeness of surgical intervention and generates predictive information for therapeutic decisions Whole genome sequencing WGS has discovered cancer driver mutations and the complex molecular profile of liver cancer In many metastatic solid tumours WGS has been used to identify a significant patient population 31 who present with a biomarker that predicts sensitivity to a drug and lacked any known resistance biomarkers for the same drug Identifying which patients possess druggable mutations will allow clinicians to make the optimal treatment decisions The next challenge is integrating WGS into scalable clinical practice
Participants with primary or secondary liver cancer will be recruited from Hampshire Hospitals NHS Foundation Trust in Basingstoke or Oxford University Hospitals NHSFoundation Trust in Oxford The incidence of treatable liver tumours is on the rise globally driven by obesity viral hepatitis and metastases from colorectal cancers Survival rates can be improved with optimised allocation of treatment options including surgical resection radiofrequency ablation embolisation chemotherapy and targeted molecular therapies including immunotherapy
The key motivation of this study is to help patients access the most suitable treatment combinations based on integrating clinical radiological and genomic data A similar integrated approach integrating radiology and pathology has been shown to improve outcomes in breast cancer care Detailed pathologic analysis of the surgical specimen from breast carcinoma biopsy provides valuable feedback to the radiologist establishes the completeness of surgical intervention and generates predictive information for therapeutic decisions Whole genome sequencing WGS has discovered cancer driver mutations and the complex molecular profile of liver cancer In many metastatic solid tumours WGS has been used to identify a significant patient population 31 who present with a biomarker that predicts sensitivity to a drug and lacked any known resistance biomarkers for the same drug Identifying which patients possess druggable mutations will allow clinicians to make the optimal treatment decisions The next challenge is integrating WGS into scalable clinical practice
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None