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OpenTrials
Completed

NCT Number: NCT01531881

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

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.

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Key information

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

    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 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.

    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.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Important dates

Study start
2006
Primary completion
2013
Study completion
2014
First posted
Feb 13, 2012
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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