Recruiting

Observational Study

Sponsor:

British Columbia Cancer Agency

Code:

NCT03202810

Conditions

Oral Cancer

Oral Premalignant Lesion

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Oral cancer is a major health problem worldwide, accounting for 274,000 new cases and 145,000 deaths annually. On average, half of the patients die within 5 years of an oral cancer diagnosis. Most troubling, however, is the lack of significant change in prognosis for this disease over the last 4 decades, even in developed nations. Even when successful, treatment of oral cancer can be devastating due to diminished quality of life and disfigurement. The key to controlling this disease is early identification of lesions that are at high risk of progression and provide effective treatment. The overall objective of the team is to integrate clinical, pathological, molecular, and imaging data to create a robust oral cancer risk model to predict the risk of progression of OPLs and to develop population-wide cost-effective prevention strategies for high-risk oral premalignancies. The project will involve 4 specific aims as described in detail below.

Aim 1. To use molecular data to stratify low-grade OPLs into high- and low-risk groups.

Aim 2. To evaluate the cost-effectiveness of various follow-up frequency that use LOH at chromosome 9p21 as a risk marker.

Aim 3: To evaluate the specificity and sensitivity of using imaging technologies as a tool for the decision of the high-grade or high-risk biopsy site.

Aim 4. To assess the clinical utility of a miRNA expression signature derived from serum collected from patients with oral cancer and OPLs.

Conditions

Oral Cancer

Oral Premalignant Lesion

Study ID

NCT03202810

Start date

Nov 15, 2011

Status verified date

Jun, 2017

Completion date

Nov 14, 2022

Anticipated

Primary completion date

Nov 14, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Is age 19 or older
  • Have an abnormal lesion in the mouth.
  • able to give informed consent to participate

Exclusion Criteria:

  • less than 19 years old

Study Design

Enrollment

360 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Cancer progression [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Catherine Poh, DDS, PhD

6046758000cpoh@dentistry.ubc.ca

Locations

BC Cancer Agency

Recruiting

Vancouver, British Columbia, Canada, V5Z 1L3

Contacts

Catherine Poh, DDS, PhD

6046758000

More Information

Sponsor

British Columbia Cancer Agency

Last update posted

Jun 29, 2017

Last verified

Jun, 2017

Keywords

  • optical imaging technology, loss of heterozygosity, prevention, miRNA, cost-effectiveness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by British Columbia Cancer Agency on 2017-06-29.