Clinical trial · Observational
Preventing Viral Pandemic Associated Risk of Cancer Death Using Less Invasive Diagnostic Tests- Liquid Biopsies
NCT04566614CI-TRIAL-00088221PREVAILctDNAcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Neoplasms | — | UNRESOLVED | — |
| Gastro Intestinal Stromal Tumour | — | UNRESOLVED | — |
| Neoplasm, Bladder | Bladder Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm, Colorectal | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm of Lung | Lung Neoplasm | ALIAS | 0.90 |
| Neoplasms Pancreatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ctDNA blood sampling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- label
- Biliary Tract Cohort
- description
- Patients with suspected biliary tract cancer will be offered ctDNA to support a diagnosis in patients with suspected early stage, locally advanced and advanced disease. This includes patients with tumours that are technically challenging to access with invasive biopsy or due to limitations in endoscopic ultrasound due to the COVID-19 pandemic. Patients with histological diagnosis will not be eligible for this study. Patients with suspected cancer will have ctDNA result (positive or negative) discussed at MDT in conjunction with PREVAIL-imaging risk stratification pathway to risk stratify in terms of cancer risk (low, intermediate and high risk), serum tumour markers and patient presentation which will dictate the appropriate treatment. Those with metastatic disease will have their treatment decision based on ctDNA result, radiology and patient characteristics after discussion between the treating clinician and patient
- interventionNames
- Other: ctDNA blood sampling
- label
- Bladder Cancer Cohort
- description
- Patients with suspected bladder cancer (localised and metastatic) will be offered ctDNA to support their diagnosis, in cases where cystoscopy and biopsy are difficult to obtain due to the COVID-19 pandemic. Patients with histological diagnosis will not be eligible for this study. A positive ctDNA result will be supportive of a diagnosis of bladder cancer, their treatment may be prioritised and decided based on this result in conjunction with radiological findings, patient presentation and after discussion between the treating physician and patient
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 PART 2: Inclusion criteria * Included in the ACCESS implementation programme * Has detectable ctDNA on Guardant360© assay * Discussion at molecular tumour board and central multi-disciplinary meeting confirming ctDNA variant is supportive of diagnosis of PC/BTC (diagnostic or consistent with) * Performance status suitable for oncological treatment * Ability to provide informed consent Exclusion criteria 1. Previously diagnosed invasive or haematological malignancy within the past 3 years 2. Outcome at the molecular tumour board not supportive of cancer diagnosis (possibly consistent or not consistent)
References
Publications (0)
Data not yet available
No reference posted for this study.