Preventing Viral Pandemic Associated Risk of Cancer Death Using Less Invasive Diagnostic Tests- Liquid Biopsies

  • STATUS
    Recruiting
  • days left to enroll
    32
  • participants needed
    112
  • sponsor
    Royal Marsden NHS Foundation Trust
Updated on 25 January 2021
cancer
lung cancer
bladder cancer
bladder tumor
lung carcinoma

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 (and/or 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.

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 (i.e. NICE (National Institute for Health and Care Excellence)/Cancer 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 112 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.

Details
Condition Pancreatic Cancer, Pancreatic Cancer, Islet Ce417ll Cancer, Colorectal Cancer, Colorectal Cancer, Colon Cancer Screening, Colon cancer; rectal cancer, bladder cancer, bladder cancer, Bladder Carcinoma, Urothelial Cancer, Biliary neoplasm, Biliary Tract Cancer, Urothelial Tract Cancer, Lung Neoplasm, Lung Cancer, Neoplasm of unspecified nature of digestive system, Digestive System Neoplasms, Colon Cancer Screening, Colon cancer; rectal cancer, Urothelial Cancer, Urothelial Tract Cancer, Islet Ce417ll Cancer, Lung Cancer, Biliary Tract Cancer, Digestive System Neoplasms, Bladder Carcinoma, Gastro Intestinal Stromal Tumour, lung tumor, bladder tumor
Treatment ctDNA blood sampling
Clinical Study IdentifierNCT04566614
SponsorRoyal Marsden NHS Foundation Trust
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants aged 18 years old
Patients with suspected malignancies of early stage colorectal cancer (FIT intermediate and high risk), early and late stage pancreatic cancer, biliary tract cancer, gastro-intestinal stromal tumours, lung cancer or bladder cancer, without a definitive histological diagnosis (including those with inconclusive biopsy result) or
Patients with histological diagnosis of lung cancer without adequate tissue for NHS genomic test directory predictive biomarker testing
Ability to provide informed consent
Patients with performance status suitable for oncological treatments (ECOG performance status 0-2)
Exclusion criterion
Patients with an established histological diagnosis adequate to support
standard of care treatment
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