Autofluorescence Detection of Oral Malignancies and Database and Biospecimen Collection to Identify Biomarkers of Head and Neck Tumor Progression

• ClinicalTrials.gov Identifier: NCT01531881
• Recruitment Status: Active, not recruiting
• First Posted: February 13, 2012
• Last Update Posted: January 6, 2021
• Sponsor: Roswell Park Cancer Institute
• Information provided by (Responsible Party): Roswell Park Cancer Institute

Study Description

Brief 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.

Condition or disease
Oral Cancer

Study Design

• Study Type: Observational
• Actual Enrollment: 240 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Autofluorescence Detection of Oral Malignancies and Database and Biospecimen Collection to Identify Biomarkers of Head and Neck Tumor Progression
• Study Start Date: March 2006
• Actual Primary Completion Date: October 2013
• Estimated Study Completion Date: October 30, 2021

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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) ]
   The first purpose of this activity is 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.

Secondary Outcome Measures :

1. 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) ]
   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.

Biospecimen Retention:   Samples With DNA

saliva, oral mucosal and tongue brushings.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Dental clinic patients

Criteria

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

Contacts and Locations

Locations

United States, New York

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Sponsors and Collaborators

Roswell Park Cancer Institute

Investigators

• Principal Investigator: Nicolas Schlecht; Roswell Park Cancer Institute

More Information

• Responsible Party: Roswell Park Cancer Institute
• ClinicalTrials.gov Identifier: NCT01531881
• Other Study ID Numbers: I 66805
• First Posted: February 13, 2012
• Last Update Posted: January 6, 2021
• Last Verified: January 2021

Additional relevant MeSH terms:

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