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

NCT ID: NCT01531881

Last Updated: 2023-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Oral Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roswell Park Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas Schlecht

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

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Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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I 66805

Identifier Type: -

Identifier Source: org_study_id

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