Oral cancer: molecular, cellular and immunological mechanisms
| ISRCTN | ISRCTN71267356 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71267356 |
| Secondary identifying numbers | 8130 |
- Submission date
- 30/03/2010
- Registration date
- 09/06/2010
- Last edited
- 25/06/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
http://www.cancerhelp.org.uk/trials/a-study-to-learn-more-about-causes-mouth-cancer
Contact information
Dr Karwan Moutasim
Scientific
Scientific
Cancer Sciences Building
Mailpoint 824, Tremona Road
Southampton
SO16 6YD
United Kingdom
Study information
| Study design | Non-randomised observational clinical laboratory study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Investigation of the molecular mechanisms promoting oral cancer development and progression |
| 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(s) | Isle of Wight, Portsmouth and South East Hampshire Research Ethics Committee, 11/01/2010, ref: 09/H0501/90 |
| 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 |
| Primary outcome measure | 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 study start date | 05/04/2010 |
| Overall study end date | 20/03/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 500 |
| 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 exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 05/04/2010 |
| Recruitment end date | 20/03/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cancer Sciences Building
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Sponsor information
Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
| Website | http://www.soton.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/0485axj58 |
Funders
Funder type
Charity
British Association of Oral and Maxillofacial Surgeons (UK)
No information available
Cancer Research UK (CRUK) (UK) (ref: 507862102)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
The Health Foundation (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
25/06/2020: No publications found.
18/11/2016: No publications found in PubMed, verifying study status with principal investigator.
