Autofluorescence Detection of Oral Malignancies and Database and Biospecimen Collection to Identify Biomarkers of Head and Neck Tumor Progression
This study is currently recruiting participants.
Verified March 2013 by Roswell Park Cancer Institute
Sponsor:
Roswell Park Cancer Institute
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01531881
First received: January 11, 2012
Last updated: March 18, 2013
Last verified: March 2013
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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.
| Estimated Enrollment: | 500 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | February 2016 |
| Estimated Primary Completion Date: | February 2016 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531881
Contacts
| Contact: AskRPCI | 877-275-7724 | AskRPCI@RoswellPark.org |
Locations
| United States, New York | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263 | |
| Contact: AskRPCI 877-275-7724 AskRPCI@RoswellPark.org | |
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: | March 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Mouth Neoplasms Neoplastic Processes Neoplasms by Site |
Neoplasms Mouth Diseases Stomatognathic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013