Condition category
Cancer
Date applied
10/11/2015
Date assigned
01/04/2016
Last edited
31/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Prof Jim McCaul

ORCID ID

Contact details

Queen Elizabeth University Hospital
1345 Govan Road
Glasgow
G51 4TF
United Kingdom
+44 141 201 1100
jmccaul@nhs.net

Type

Public

Additional contact

Miss Jacqueline Quantrill

ORCID ID

Contact details

Bradford Institute for Health Research
Temple Bank House
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
+44 1274 383921
jaqueline.quantrill@bthft.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

McCaul 01/2014

Study information

Scientific title

A multi-centre, randomised controlled trial assessing the effectiveness of Lugol's Iodine in Surgical managemenT of Epithelial dysplasia in the oRal cavity and oropharynx

Acronym

LISTER

Study hypothesis

Does intraoperative visualisation of dysplastic mucosa with Lugol’s Iodine assist in improving accuracy of excision of epithelial dysplasia of oral cavity and oropharynx?

Ethics approval

London-Harrow Research Ethics Committee, 13/10/2016, ref: 16/LO/0857

Study design

Prospective multicentre phase III randomised controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Epithelial dysplasia in the oral cavity and oropharynx

Intervention

1. Standard Treatment Group: Surgical excision of epithelial dysplasia as per usual practice
2. Intervention Treatment Group: Surgical excision of epithelial dysplasia assisted by visualisation with Lugol’s iodine

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Rates of surface dysplasia or carcinoma-in-situ at surface mucosal margins

Secondary outcome measures

1. Two-year incidence of histologically confirmed transformation to SCC in the oral/cavity/oropharynx
2. Occult SCC diagnosed histopathologically in excised mucosa
3. Surface area of mucosa excised
4. Extent of margin clearance in mm
5. Surgeon decision to re-excise at the same site following positive margins
6. Estimate of the two year recurrence rates of oral dysplasia
7. Acceptability of the technique to surgeons (intervention treatment group)
8. Safety of the technique (intervention treatment group)
9. Assessment of Quality of Life changes

Overall trial start date

01/01/2014

Overall trial end date

01/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Provision of written informed consent
2. Age≥ 18 years old
3. Epithelial dysplasia of the oral cavity or oropharynx, undergoing primary surgical excision under general anaesthesia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 (to increase to 388 after initial feasibility)

Participant exclusion criteria

1. Previous surgery or radiotherapy for head and neck cancer
2. Allergy to iodine
3. Previous diagnosis of head & Neck SCC in the past 5 years or active malignancy within 2 years of randomisation (except basal cell carcinoma or carcinoma of the cervix in-situ)

Recruitment start date

01/12/2015

Recruitment end date

01/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

London North West Healthcare Trust
Northwick Park Hospital
HA1 3UJ
United Kingdom

Trial participating centre

Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Trial participating centre

North Manchester General Hospital
The Pennine Acute Hospitals NHS Trust D Block Square, Level 4 Delaunays Road, Crumpsall
Manchester
M8 5RB
United Kingdom

Trial participating centre

Ninewells Hospital and Dundee University Medicals
Dundee
DD1 9SY
United Kingdom

Trial participating centre

Queen Elizabeth Hospital
1345 Govan Road
Glasgow
G51 4TF
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow and Clyde

Sponsor details

West Glasgow Ambulatory Care Hospital
Dalnair Street
Glasgow
G3 8SW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Oracle Cancer Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The findings will be disseminated locally at clinical governance meetings, at national and international head and neck cancer scientific meetings (BAOMS, BAHNO, IAOO). We will take advice from our local patient research forum on how to best reach the local population with the findings. We aim to publish the findings in the British Journal of Oral and Maxillofacial Surgery within six months of the final patient visit.

Intention to publish date

01/12/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

31/10/2017: Internal review. 27/07/2017: Ethical approval was added. 25/07/2017: Miss Kayleigh Gilbert (kayleigh.gilbert@nhs.net) has been removed as a study contact. Ms Jacqueline Quantrill has been added as a study contact. Mr McCaul's institutional address has been changed from Northwick Park Hospital to Queen Elizabeth University Hospital. Overall trial end date has been changed from 01/12/2016 to 01/12/2018. Recruitment end date has been changed from 01/06/2016 to 01/06/2018. Four trial participating centres have been added (Bradford Royal Infirmary, The Pennine Acute Hospitals NHS Trust North Manchester General Hospital, Ninewells Hospital and Dundee University Medicals, Queen Elizabeth Hospital. The Royal Marsden Hospital has been removed as a trial participating site. The study sponsor has been changed from London North West Healthcare NHS Trust to NHS Greater Glasgow and Clyde. 21/12/2016: Cancer Help UK lay summary link added.