Brief Title
Autofluorescence Detection of Oral Malignancies and Database and Biospecimen Collection to Identify Biomarkers of Head and Neck Tumor Progression
Official Title
Autofluorescence Detection of Oral Malignancies and Database and Biospecimen Collection to Identify Biomarkers of Head and Neck Tumor Progression
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.
Study Type
Observational
Primary Outcome
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
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.
Condition
Oral Cancer
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
240
Start Date
March 2006
Completion Date
March 2023
Primary Completion Date
October 2013
Eligibility 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
Gender
All
Ages
21 Years - 99 Years
Accepts Healthy Volunteers
No
Contacts
Nicolas Schlecht, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01531881
Organization ID
I 66805
Responsible Party
Sponsor
Study Sponsor
Roswell Park Cancer Institute
Study Sponsor
Nicolas Schlecht, Principal Investigator, Roswell Park Cancer Institute
Verification Date
February 2022