Condition category
Cancer
Date applied
30/03/2010
Date assigned
09/06/2010
Last edited
18/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Karwan Moutasim

ORCID ID

Contact details

Cancer Sciences Building
Mailpoint 824
Tremona Road
Southampton
SO16 6YD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8130

Study information

Scientific title

Investigation of the molecular mechanisms promoting oral cancer development and progression

Acronym

Study hypothesis

Oral cancer (OSCC) is the 8th most common cancer worldwide, representing about 4% of all malignancies. In the UK, the incidence has increased dramatically over the last 20 years, particularly in young non-smokers, with around 5,000 new cases each year. Compared with many cancers, OSCC remains a relatively understudied disease. And despite advances in surgery and radiotherapy, which remain the standard treatment options, the mortality rate has remained unchanged for decades, with a 5-year survival rate of around 50%.

Oral cancer may be preceded by a premalignant, histologically dysplastic lesion, usually presenting clinically as a white or red patch in the mouth. However, only around 10 - 15% of patients diagnosed with oral dysplasia will develop oral cancer.

Ethics approval

Isle of Wight, Portsmouth and South East Hampshire Research Ethics Committee, 11/01/2010, ref: 09/H0501/90

Study design

Non-randomised observational clinical laboratory study

Primary study design

Observational

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

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

Condition

Topic: National Cancer Research Network; Subtopic: Head and Neck Cancer; Disease: Head and Neck

Intervention

1. Surgical biopsy
2. Venesection

Study entry: registration only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To gain an increased understanding of the cellular and molecular biology of oral/oropharyngeal cancer. This will involve identifying biomarkers which may predict patient prognosis and/or response to treatment.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

05/04/2010

Overall trial end date

20/03/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Clinical suspicion of premalignant oral/oropharyngeal lesion and/or condition
2. Clinical and histopathologic diagnosis of oral/oropharyngeal cancer
3. Male and female, lower age limit of 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 500

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

05/04/2010

Recruitment end date

20/03/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cancer Sciences Building
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

Southampton University Hospitals NHS Trust (UK)

Sponsor details

Tremona Road
Southampton
SO16 6YD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.soton.ac.uk/

Funders

Funder type

Charity

Funder name

British Association of Oral and Maxillofacial Surgeons (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cancer Research UK (CRUK) (UK) (ref: 507862102)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

The Health Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/11/2016: No publications found in PubMed, verifying study status with principal investigator.