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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01531881
First received: January 11, 2012
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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.


Condition
Oral Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Autofluorescence Detection of Oral Malignancies and Database and Biospecimen Collection to Identify Biomarkers of Head and Neck Tumor Progression

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

saliva, oral mucosal and tongue brushings.


Enrollment: 240
Study Start Date: March 2006
Estimated Study Completion Date: February 2016
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Dental clinic patients

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531881

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Maureen Sullivan, DDS Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01531881     History of Changes
Other Study ID Numbers: I 66805
Study First Received: January 11, 2012
Last Updated: January 31, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on September 30, 2014