Innovative Approach to Triage Oral Precancer

NCT03202810 | Unknown

• 1 other identifier: H11-02516
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cancer progression

  the lesion progresses into high-grade preinvasive lesion or cancer

  10 years

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• less than 19 years old

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• BC Cancer Foundation: collaborator
• University of British Columbia: collaborator

Study Sites (1)

BC Cancer Agency

Vancouver, British Columbia, V5Z 1L3, Canada

RECRUITING

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.

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Catherine Poh

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Poh, DDS, PhD

CONTACT

6046758000; cpoh@dentistry.ubc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: June 29, 2017
• Study Start: November 15, 2011
• Primary Completion: November 14, 2021
• Study Completion: November 14, 2022
• Last Updated: June 29, 2017

Record last verified: 2017-06

Locations

CA (1)