Oral cancer: molecular, cellular and immunological mechanisms
| ISRCTN | ISRCTN71267356 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71267356 |
| Protocol serial number | 8130 |
| Sponsor | Southampton University Hospitals NHS Trust (UK) |
| Funders | British Association of Oral and Maxillofacial Surgeons (UK), Cancer Research UK (CRUK) (UK) (ref: 507862102), The Health Foundation (UK) |
- 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 of protocol
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
| Primary study design | Observational |
|---|---|
| Study design | Non-randomised observational clinical laboratory study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Investigation of the molecular mechanisms promoting oral cancer development and progression |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
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. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 20/03/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 500 |
| Key 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 |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 05/04/2010 |
| Date of final enrolment | 20/03/2015 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Cancer Sciences Building
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
25/06/2020: No publications found.
18/11/2016: No publications found in PubMed, verifying study status with principal investigator.
