Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04566614
Status:
RECRUITING
Last Update Posted:
2023-02-22
First Post:
2020-06-02
Brief Title:
Preventing Viral Pandemic Associated Risk of Cancer Death Using Less Invasive Diagnostic Tests- Liquid Biopsies
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Royal Marsden NHS Foundation Trust
Study Overview
Official Title:
Preventing Viral Pandemic Associated Risk of Cancer Death Using Less Invasive Diagnostic Tests- Liquid Biopsies
Status:
RECRUITING
Status Verified Date:
2023-02
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:
PREVAILctDNA
Brief Summary:
The purpose of this study is to investigate the feasibility of using ctDNA to support cancer diagnosis and risk stratification where invasive aerosol generating testing andor tissue biopsy is challenging due to infection risk technical impracticalities and resource limitations such as during the COVID-19 pandemic and the subsequent recovery period
Detailed Description:
This is a prospective single-centre cohort pilot study using ctDNA informed treatment decisions If the pilot study is successful within certain tumour types then this protocol may be extended to investigate further the benefit of ctDNA informed treatment decision in those tumour types
Patients with suspected malignancy for whom invasive biopsy for definitive histological diagnosis is challenging either due to COVID-19-related resource limitations infection control or technical feasibility will be considered for this study In this setting liquid biopsy may be used in lieu of tissue biopsy to facilitate treatment or may be used to prioritise standard of care invasive diagnostic tests The former includes patients who require repeat biopsies for genomic analysis following non-informative results where these would inform standard of care treatment ie NICE National Institute for Health and Care ExcellenceCancer Drug Fund CDF approved drugs Tumour types included in this study are therefore those where invasive aerosol generating diagnostic tests such as bronchoscopy gastrointestinal endoscopy including endoscopic ultrasound EUS are part of the standard diagnostic pathway and where capacity for these tests has become severely constrained during and likely after the COVID-19 pandemic Tumour types affected include some suspected biliary tract bladder colorectal GIST lung and pancreatic cancers
The study is planned to continue until a total of 144 patients have been enrolled This is anticipated to take up to 12-18 months Follow-up will continue until patients have diagnosis made based on ctDNA result and treatment decision made deferred or immediate
Potential patients will be identified in and will usually at the multidisciplinary team MDT meeting They will give consent to participate in the trial and offered a liquid biopsy ctDNA in lieu of a tissue biopsy if considered suitable for PREVAIL - ctDNA This may include patients who require repeat biopsies for further genomic analyses when repeat biopsies are not feasible where liquid biopsy may support prioritisation for invasive diagnostics earlier ctDNA analysis will involve copy number variant detection and low coverage whole genomic sequencing ctDNA gene panels have already been validated against tissue based molecular diagnostics for paediatrics ct_PAED and colorectal cancer ct_GI
This analysis will be performed in an accredited clinical diagnostic laboratory Translational Research Laboratory Institute of Cancer Research Patients will be stratified for treatment or further investigation based on their ctDNA result either positive or negative suspected tumour type radiological including PREVAIL-imaging risk stratification pathway and clinical characteristics
PREVAIL ctDNA- Part 2 Study
PREVAIL part 2 is a multi-centre prospective study assessing the impact of Guardant360 liquid biopsy in patients with radiologically suspicious pancreatic cancer PC and biliary tract cancer BTCwithout histological confirmation of malignancy
Liquid biopsies will be implemented into the routine diagnostic pathway across 6 RMP sites for patients with radiologically suspicious stage IIIIV PCBTC as part of the ACCESS implementation programme Over 12 months approximately 650 patients will be identified at individual sites by the local team when seen for an invasive procedure and referred in parallel to the Guardant360 test These patients will proceed through an invasive diagnostic pathway as is standard of care and have a liquid biopsy as a new standard of care Most patients will undergo both invasive tissue biopsy and liquid biopsy
Patients with informative liquid biopsy result but without a histological diagnosis of cancer either due to inconclusive biopsy result or if the invasive procedure hasnt been performed will be considered suitable for the study Only patients with detectable ctDNA without histological confirmation will be suitable for this study approximately ΒΌ of patients entering the ACCESS programme The study is planned to run parallel to the ACCESS implementation programme and it aims to enrole 150 patients
As part of this study treatment may be recommended based on the liquid biopsy result Patients with an invasive biopsy result which is suitable to guide treatment will not be eligible
ctDNA results will be discussed at the molecular tumour board MTB to provide clinical context and validity of the genomic result In addition all patients will be discussed at a central upper gastrointestinal cancer multidisciplinary team meeting MDM to discuss treatment based on ctDNA results Treating clinicians will have access to the MTB outcome and patients may be treated based on the ctDNA result in the context of symptoms tumour markers and imaging results as a complete diagnostic package
Patients with suspected malignancy for whom invasive biopsy for definitive histological diagnosis is challenging either due to COVID-19-related resource limitations infection control or technical feasibility will be considered for this study In this setting liquid biopsy may be used in lieu of tissue biopsy to facilitate treatment or may be used to prioritise standard of care invasive diagnostic tests The former includes patients who require repeat biopsies for genomic analysis following non-informative results where these would inform standard of care treatment ie NICE National Institute for Health and Care ExcellenceCancer Drug Fund CDF approved drugs Tumour types included in this study are therefore those where invasive aerosol generating diagnostic tests such as bronchoscopy gastrointestinal endoscopy including endoscopic ultrasound EUS are part of the standard diagnostic pathway and where capacity for these tests has become severely constrained during and likely after the COVID-19 pandemic Tumour types affected include some suspected biliary tract bladder colorectal GIST lung and pancreatic cancers
The study is planned to continue until a total of 144 patients have been enrolled This is anticipated to take up to 12-18 months Follow-up will continue until patients have diagnosis made based on ctDNA result and treatment decision made deferred or immediate
Potential patients will be identified in and will usually at the multidisciplinary team MDT meeting They will give consent to participate in the trial and offered a liquid biopsy ctDNA in lieu of a tissue biopsy if considered suitable for PREVAIL - ctDNA This may include patients who require repeat biopsies for further genomic analyses when repeat biopsies are not feasible where liquid biopsy may support prioritisation for invasive diagnostics earlier ctDNA analysis will involve copy number variant detection and low coverage whole genomic sequencing ctDNA gene panels have already been validated against tissue based molecular diagnostics for paediatrics ct_PAED and colorectal cancer ct_GI
This analysis will be performed in an accredited clinical diagnostic laboratory Translational Research Laboratory Institute of Cancer Research Patients will be stratified for treatment or further investigation based on their ctDNA result either positive or negative suspected tumour type radiological including PREVAIL-imaging risk stratification pathway and clinical characteristics
PREVAIL ctDNA- Part 2 Study
PREVAIL part 2 is a multi-centre prospective study assessing the impact of Guardant360 liquid biopsy in patients with radiologically suspicious pancreatic cancer PC and biliary tract cancer BTCwithout histological confirmation of malignancy
Liquid biopsies will be implemented into the routine diagnostic pathway across 6 RMP sites for patients with radiologically suspicious stage IIIIV PCBTC as part of the ACCESS implementation programme Over 12 months approximately 650 patients will be identified at individual sites by the local team when seen for an invasive procedure and referred in parallel to the Guardant360 test These patients will proceed through an invasive diagnostic pathway as is standard of care and have a liquid biopsy as a new standard of care Most patients will undergo both invasive tissue biopsy and liquid biopsy
Patients with informative liquid biopsy result but without a histological diagnosis of cancer either due to inconclusive biopsy result or if the invasive procedure hasnt been performed will be considered suitable for the study Only patients with detectable ctDNA without histological confirmation will be suitable for this study approximately ΒΌ of patients entering the ACCESS programme The study is planned to run parallel to the ACCESS implementation programme and it aims to enrole 150 patients
As part of this study treatment may be recommended based on the liquid biopsy result Patients with an invasive biopsy result which is suitable to guide treatment will not be eligible
ctDNA results will be discussed at the molecular tumour board MTB to provide clinical context and validity of the genomic result In addition all patients will be discussed at a central upper gastrointestinal cancer multidisciplinary team meeting MDM to discuss treatment based on ctDNA results Treating clinicians will have access to the MTB outcome and patients may be treated based on the ctDNA result in the context of symptoms tumour markers and imaging results as a complete diagnostic package
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