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

NCT01531881 | Completed DMC

• 1 other identifier: I 66805
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Cancer

Outcome Measures

Primary Outcomes (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.

  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.

  Once at time of consent (day 1)

Secondary Outcomes (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.

  Once at time of consent (day 1)

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Dental clinic patients

You may qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

saliva, oral mucosal and tongue brushings.

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Nicolas Schlecht

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: February 13, 2012
• Study Start: March 1, 2006
• Primary Completion: October 1, 2013
• Study Completion: January 1, 2014
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

US (1)