Working… Menu

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. Identifier: NCT03202810
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : June 29, 2017
BC Cancer Foundation
University of British Columbia
Information provided by (Responsible Party):
British Columbia Cancer Agency

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.

Condition or disease
Oral Cancer Oral Premalignant Lesion

Show Show detailed description

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

Primary Outcome Measures :
  1. Cancer progression [ Time Frame: 10 years ]
    the lesion progresses into high-grade preinvasive lesion or cancer

Biospecimen Retention:   Samples With DNA
Formalin-fixed paraffin-embeded biopsy specimens, blood samples for serum, plasma, and DNA; fresh frozen tissue of biopsy specimens; exfoliated cells.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with pathology-proven oral precancers, i.e., verrucous hyperplasia, mild dysplasia, moderate dsyplasia are willing to give informed consent for the study.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03202810

Layout table for location contacts
Contact: Catherine Poh, DDS, PhD 6046758000 ext 7072

Layout table for location information
Canada, British Columbia
BC Cancer Agency Recruiting
Vancouver, British Columbia, Canada, V5Z 1L3
Contact: Catherine Poh, DDS, PhD    6046758000      
Sponsors and Collaborators
British Columbia Cancer Agency
BC Cancer Foundation
University of British Columbia
Layout table for investigator information
Principal Investigator: Catherine Poh British Columbia Cancer Agency
Additional Information:

Layout table for additonal information
Responsible Party: British Columbia Cancer Agency Identifier: NCT03202810    
Other Study ID Numbers: H11-02516
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by British Columbia Cancer Agency:
optical imaging technology, loss of heterozygosity, prevention, miRNA, cost-effectiveness
Additional relevant MeSH terms:
Layout table for MeSH terms
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases