Use of a non-endoscopic immunocytological device (Cytosponge™) for post chemoradiotherapy surveillance in patients with oesophageal cancer in the UK (CYTOFLOC): A multicentre feasibility study.
Chemoradiation
Cytosponge
Oesophageal Cancer
Radiation
Surveillance
Journal
EClinicalMedicine
ISSN: 2589-5370
Titre abrégé: EClinicalMedicine
Pays: England
ID NLM: 101733727
Informations de publication
Date de publication:
Nov 2022
Nov 2022
Historique:
received:
04
07
2022
revised:
30
08
2022
accepted:
31
08
2022
entrez:
3
10
2022
pubmed:
4
10
2022
medline:
4
10
2022
Statut:
epublish
Résumé
Effective surveillance strategies are required for patients diagnosed with oesophageal squamous cell carcinoma (OSCC) or adenocarcinoma (OAC) for whom chemoradiotherapy (CRT) is used as a potentially-curative, organ-sparing, alternative to surgery. In this study, we evaluated the safety, acceptability and tolerability of a non-endoscopic immunocytological device (the Cytosponge™) to assess treatment response following CRT. This multicentre, single-arm feasibility trial took place in 10 tertiary cancer centres in the UK. Patients aged at least 16 years diagnosed with OSCC or OAC, and who were within 4-16 weeks of completing definitive or neo-adjuvant CRT, were included. Participants were required to have a Mellow-Pinkas dysphagia score of 0-2 and be able to swallow tablets. All patients underwent a single Cytosponge™ assessment in addition to standard of care (which included post-treatment endoscopic evaluation with biopsy for patients undergoing definitive CRT; surgery for those who received neo-adjuvant CRT). The primary outcome was the proportion of consented, evaluable patients who successfully underwent Cytosponge™ assessment. Secondary and tertiary outcomes included safety, study consent rate, acceptance rate, the suitability of obtained samples for biomarker analysis, and the comparative efficacy of Cytosponge™ to standard histology (endoscopy and biopsy or post-resection specimen) in assessing for residual disease. The trial is registered with ClinicalTrials.gov, NCT03529669. Between 18 Use of the Cytosponge Cancer Research UK, National Institute for Health Research, Medical Research Council.
Sections du résumé
Background
UNASSIGNED
Effective surveillance strategies are required for patients diagnosed with oesophageal squamous cell carcinoma (OSCC) or adenocarcinoma (OAC) for whom chemoradiotherapy (CRT) is used as a potentially-curative, organ-sparing, alternative to surgery. In this study, we evaluated the safety, acceptability and tolerability of a non-endoscopic immunocytological device (the Cytosponge™) to assess treatment response following CRT.
Methods
UNASSIGNED
This multicentre, single-arm feasibility trial took place in 10 tertiary cancer centres in the UK. Patients aged at least 16 years diagnosed with OSCC or OAC, and who were within 4-16 weeks of completing definitive or neo-adjuvant CRT, were included. Participants were required to have a Mellow-Pinkas dysphagia score of 0-2 and be able to swallow tablets. All patients underwent a single Cytosponge™ assessment in addition to standard of care (which included post-treatment endoscopic evaluation with biopsy for patients undergoing definitive CRT; surgery for those who received neo-adjuvant CRT). The primary outcome was the proportion of consented, evaluable patients who successfully underwent Cytosponge™ assessment. Secondary and tertiary outcomes included safety, study consent rate, acceptance rate, the suitability of obtained samples for biomarker analysis, and the comparative efficacy of Cytosponge™ to standard histology (endoscopy and biopsy or post-resection specimen) in assessing for residual disease. The trial is registered with ClinicalTrials.gov, NCT03529669.
Findings
UNASSIGNED
Between 18
Interpretation
UNASSIGNED
Use of the Cytosponge
Funding
UNASSIGNED
Cancer Research UK, National Institute for Health Research, Medical Research Council.
Identifiants
pubmed: 36187722
doi: 10.1016/j.eclinm.2022.101664
pii: S2589-5370(22)00394-7
pmc: PMC9519482
doi:
Banques de données
ClinicalTrials.gov
['NCT03529669']
Types de publication
Journal Article
Langues
eng
Pagination
101664Subventions
Organisme : Cancer Research UK
ID : 28870
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/W014122/1
Pays : United Kingdom
Informations de copyright
© 2022 Published by Elsevier Ltd.
Déclaration de conflit d'intérêts
The Cytosponge™ technology including the device and TFF3 biomarker has been licensed by the MRC to Covidien (now Medtronic). R.C.F. and M.O.D. are named on patents related to this test. R.C.F. and M.O.D. are shareholders and consultants for Cyted, an early detection company. All other authors declare no competing interests.
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