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


N/A
21 Years
N/A
Open (Enrolling)
Both
Oral Cancer

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome 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.

Outcome Description:

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.

Outcome Time Frame:

Once at time of consent (day 1)

Safety Issue:

No

Principal Investigator

Maureen Sullivan, DDS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

I 66805

NCT ID:

NCT01531881

Start Date:

March 2006

Completion Date:

February 2016

Related Keywords:

  • Oral Cancer
  • Head and Neck Neoplasms
  • Mouth Neoplasms
  • Neoplastic Processes

Name

Location

Roswell Park Cancer Institute Buffalo, New York  14263