Innovative Approach to Triage Oral Precancer (iTOP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03202810|
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : June 29, 2017
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.
|Condition or disease|
|Oral Cancer Oral Premalignant Lesion|
Show Detailed Description
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||360 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||Biomarker-driven Approach to Develop Population-wide Cost-effective Prevention Strategies for High-risk Oral Premalignancies|
|Actual Study Start Date :||November 15, 2011|
|Estimated Primary Completion Date :||November 14, 2021|
|Estimated Study Completion Date :||November 14, 2022|
- Cancer progression [ Time Frame: 10 years ]the lesion progresses into high-grade preinvasive lesion or cancer
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202810
|Contact: Catherine Poh, DDS, PhD||6046758000 ext email@example.com|
|Canada, British Columbia|
|BC Cancer Agency||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 1L3|
|Contact: Catherine Poh, DDS, PhD 6046758000|
|Principal Investigator:||Catherine Poh||British Columbia Cancer Agency|