Overview

This trial is active, not recruiting.

Condition oral cancer
Sponsor Roswell Park Cancer Institute
Start date March 2006
End date January 2014
Trial size 240 participants
Trial identifier NCT01531881, I 66805

Summary

This research may help dentists or surgeons to better detect areas in the mouth that are either prone to cancer or are early cancers. The earlier the detection on cancer in the mouth, the better the chance that treatment or prevention can be more effective.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
to investigate whether the use of a fluorescent light in the mouth can detect precancers or early cancers that are not seen on normal clinical examination.
time frame: Once at time of consent (day 1)

Secondary Outcomes

Measure
The second purpose is to collect other samples from the mouth in hopes to identify changes in the proteins and/or genes that will help identify how cancers start in the mouth.
time frame: Once at time of consent (day 1)

Eligibility Criteria

Male or female participants from 21 years up to 99 years old.

Inclusion Criteria: Patients with a history of suspicious lesions or currant suspicious lesions: - No history of CIS or HNSCC - History of clinically suspicious oral/oral pharyngeal lesions. - Over 21 years old - Not actively under treatment for any other type of malignancy, except Non-Melanoma Skin Cancer (NMSC) - Must be willing to sign consent, have AFL screening with biopsies and sample collection, must be willing to complete a social and health history questionnaire Patients with biopsy proven dysplasia, CIS or HNSCC prior to treatment: - Patients with biopsy proven dysplasia, CIS or HNSCC without a prior history of an antineoplastic treatment, including chemo/radiation and Photodynamic Therapy - Biopsy performed at an outside institution and referred for evaluation for treatment, or biopsied here at RPCI and proceeding for further care. - Over 21 years of age. - Must be willing to sign consent, have AFL screening with biopsies and sample collection, must be willing to complete a social and health history questionnaire Patients with clinically treated CIS or HNSCC amd no evidence of disease (NED): - Patients with prior history of HNSCC, previously treated with either surgery alone or combination of therapy, including Head and Neck radiation, with or without chemotherapy and Photodynamic Therapy including at least 3 months following completion of definitive treatment. - Over 21 years of age - Must be willing to sign consent, have AFL screening with biopsies and sample collection, must be willing to complete a social and health history questionnaire

Additional Information

Official title Autofluorescence Detection of Oral Malignancies and Database and Biospecimen Collection to Identify Biomarkers of Head and Neck Tumor Progression
Principal investigator Mary Reid, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Roswell Park Cancer Institute.