Evaluation of OraTest in Combination With Visual Examination in the Improved Detection of Oral Mucosal Lesions Suspicious of Serious Pathology in High-Risk Patients for the Purpose of Referral to the Health Care Professional Experienced in Oral Cancer: Phase III Clinical Trial Comparing the Sensitivity and Assessing the Specificity of OraTest in Combination With Visual Examination and Visual Examination Alone in Patients at High Risk as Defined by Age and Lifestyle Factors (ZIL-401)
OraTest® is a blue dye that is designed to stain cancer cells differently than normal cells.
SCHEDULED EVALUATION (FIRST VISIT):
Before you can start treatment on this study, you will have "screening tests." These tests
will help the doctor decide if you are eligible to take part in this study. Your medical
history will be recorded. Women who are able to have children must have a negative urine
pregnancy test. Your heart rate, breathing, temperature, and blood pressure will be
measured before as well as after the first visit.
Visual Exam - If you are found to be eligible to take part in this study, you will have a
visual examination where a doctor (Examiner #1) will look inside your mouth very carefully
to look for any abnormal lesions and check the glands in your neck. This is called the
Rinse Staining Procedure (OraTest®) - A second doctor (Examiner #2) will perform another
oral exam, followed by the new test using OraTest®. This new test uses a blue dye which may
stain any potential cancer blue so it may make it easier for the doctor to detect any
abnormal lesions in your mouth. You will be asked not to have intensely-colored sweets like
lollipops or drinks like black currant juice within 24 hours of your scheduled visit. First
you will rinse your mouth with about 6 teaspoons of vinegar solution for about 20 seconds
and spit it out. Next you will rinse your mouth with 6 teaspoons of water for 20 seconds
and spit it out. Then you will rinse your mouth with about 2 teaspoons of OraTest® for 20
seconds and spit it out. Then you will rinse your mouth with about 6 teaspoons of vinegar
solution for 20 seconds and then spit it out. Then you will rinse your mouth with 6
teaspoons of water for 20 seconds and spit it out. Examiner 2 will then check and see if
any abnormal tissue absorbed the dye.
If no suspicious lesions are found by either doctor, you will have completed the study. You
will be asked to notify the clinic, by phone, if any side effects occur within 7 days after
your visit. If you are unable to phone the clinic, you will be given diary cards to record
these side effects. The diary cards are to be mailed to the doctor in the pre-stamped
envelope given to you.
If any suspicious lesions are found by either doctor (or both), then you will be asked to
return in about 2 weeks to confirm the result. This is called the Confirmation Exam.
CONFIRMATION EXAM (SECOND VISIT):
At the visit to confirm the result, you will be examined by the same doctor(s) who found the
suspicious lesion(s). The doctor(s) will use the same examination method that was used
during the first visit. Your heart rate, breathing, temperature, and blood pressure will be
measured before as well as after the second visit.
If you have any suspicious lesions, a specialist at M. D. Anderson will biopsy your
lesion(s), at this second visit or within 5 days after the visit. During the biopsy, the
doctor may use the OraTest® cotton swab to help locate the suspicious spot. If the dye is
used at the biopsy visit, your heart rate, breathing, temperature, and blood pressure will
be measured before and after the use of OraTest®. After locating the spot, the doctor will
perform the biopsy. This means that some tissue lining in your mouth from the suspicious
area will be removed. Some of your tissue will be sent to a laboratory for diagnosis. Your
doctor will decide the type of care you may need based on the results of the biopsy. The
biopsy procedure is standard practice and may happen even if you did not participate in this
study. After the biopsy is taken of the lesion, you will have completed the study.
If a suspicious lesion is found and you are required to have a biopsy, a sample of tissue
from the biopsy will be sent to a laboratory outside of M.D. Anderson for review and
diagnosis. Medical research including genetic testing, chromosomal analysis and other tests
may be performed on your biopsy. These samples cannot be returned to you because the tissue
is destroyed during the genetic tests. Before your tissue is sent to the outside laboratory
your name and any personal identifying information will be coded to protect your privacy.
M. D. Anderson will not have oversight of any leftover tissue and/or blood that will be
banked by BRT Laboratories Inc. for additional research.
If no suspicious lesions are seen at this second visit, then you have completed the study.
If the dye was used during the exam, then you will be asked to notify the clinic by phone if
any side effects occur within 7 days after your visit. If you are unable to phone the
clinic, you will be given diary cards to record these side effects. The diary cards are to
be mailed to the doctor in the pre-stamped envelope given to you.
This is an investigational study. OraTest® has not yet been FDA approved for commercial
use. All study procedures and OraTest® will be provided free of charge; the Sponsor will
pay for the study drug and pregnancy test if necessary. If further standard of care is
needed (for example, due to abnormalities found), you and/or your insurance company will be
responsible for the cost. Insurance companies and Medicare may not pay for the costs of
some research studies like this one. If your insurance company does not cover the cost of
care, then you will have to pay these costs. You have the right to ask what it will cost
you to take part in this study or to have other treatments. If you withdraw from the study
early, you will only be paid for the portion of the study that you completed. Up to 4000
patients will take part in this multicenter study. Up to 50 will be enrolled at M. D.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Ratio of Sensitivity of OraTest + Visual Exam Versus Sensitivity of Visual Exam Alone
Two (2) scheduled visits for visual examination.
Mark Chambers, DMD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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