NCT03468634

Brief Summary

To develop and endoscopic Raman spectroscopy probe for delivery down and channel in an endoscope to make near instant assessments of the condition of the oesophagus without the need for expensive and distressing tissue removal (biopsies).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
5.5 years until next milestone

Study Start

First participant enrolled

September 21, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2024

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

January 11, 2018

Last Update Submit

April 24, 2024

Conditions

Barrett EsophagusEsophageal Cancer

Keywords

endoscopyRaman spectroscopy

Outcome Measures

Primary Outcomes (1)

  • Device safety testing (no detectable damage in biopsy samples when reviewed by histopathology)

    Testing of the device for clinical application to demonstrate its use is safe and that is able to acquire diagnostic-quality (see outcome 2) spectra in less than 5 seconds from within the oesophagus. Samples illuminated will be biopsied and sent for routine histopathological analysis.

    6 months

Secondary Outcomes (1)

  • Diagnostic model developed (algorithm able to discriminate disease with >50% specificity and >50% sensitivity)

    6 months

Study Arms (8)

Adenocarcinoma

EXPERIMENTAL

patients diagnosed with adenocarcinoma

Diagnostic Test: endoscopy

Squamous cell cancer

EXPERIMENTAL

patients diagnosed with squamous cell cancer

Diagnostic Test: endoscopy

Other

EXPERIMENTAL

patients diagnosed with another condition

Diagnostic Test: endoscopy

Barrett's oesophagus

EXPERIMENTAL

patients diagnosed with Barrett's oesophagus

Diagnostic Test: endoscopy

Low-grade dysplasia

EXPERIMENTAL

patients diagnosed with low-grade dysplasia

Diagnostic Test: endoscopy

High-grade dysplasia

EXPERIMENTAL

patients diagnosed with high-grade dysplasia

Diagnostic Test: endoscopy

Indefinite for dysplasia

EXPERIMENTAL

patients where the diagnosis is unclear

Diagnostic Test: endoscopy

no dysplasia

EXPERIMENTAL

patients not diagnosed with any cancer

Diagnostic Test: endoscopy

Interventions

endoscopyDIAGNOSTIC_TEST

Oesophageal endoscopy with biopsy

Also known as: EGD (esophagogastro duodenoscopy), upper GI endoscopy
AdenocarcinomaBarrett's oesophagusHigh-grade dysplasiaIndefinite for dysplasiaLow-grade dysplasiaOtherSquamous cell cancerno dysplasia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Barrett's oesophagus

You may not qualify if:

  • Unfit for endoscopic and biopsy assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gloucestershire Hospitals NHS Foundation Trust

Gloucester, Gloucestershire, GL1 3NN, United Kingdom

Location

Related Publications (2)

  • Isabelle M, Dorney J, Lewis A, Lloyd GR, Old O, Shepherd N, Rodriguez-Justo M, Barr H, Lau K, Bell I, Ohrel S, Thomas G, Stone N, Kendall C. Multi-centre Raman spectral mapping of oesophageal cancer tissues: a study to assess system transferability. Faraday Discuss. 2016 Jun 23;187:87-103. doi: 10.1039/c5fd00183h.

    PMID: 27048868BACKGROUND

  • Kendall C, Stone N, Shepherd N, Geboes K, Warren B, Bennett R, Barr H. Raman spectroscopy, a potential tool for the objective identification and classification of neoplasia in Barrett's oesophagus. J Pathol. 2003 Aug;200(5):602-9. doi: 10.1002/path.1376.

    PMID: 12898596BACKGROUND

Related Links

MeSH Terms

Conditions

Barrett EsophagusEsophageal Neoplasms

Interventions

EndoscopyEndoscopy, Digestive System

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeDiagnostic Techniques, Digestive SystemDigestive System Surgical Procedures

Study Officials

  • Oliver Old, BMedSc MBChB

    Gloucestershire Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2018

First Posted

March 16, 2018

Study Start

September 21, 2023

Primary Completion

April 23, 2024

Study Completion

April 23, 2024

Last Updated

April 25, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)