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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00537199 |
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Date of registration:
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26/09/2007 |
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Primary sponsor: |
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Public title:
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OraTest in Combination With Visual Examination and Visual Examination Alone
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Scientific title:
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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) |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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1 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00537199 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Mark Chambers, DMD |
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Address:
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Telephone:
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Email:
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Affiliation:
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M.D. Anderson Cancer Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. High risk of oral cancer as defined by a twenty-pack/year cigarette smoking history
or equivalent and is either a current smoker or has quit smoking within the last 24
months. Twenty-pack/year equivalent is defined as ½ pack/day for 40 years, or one
pack/day for 20 years, or 2 packs/day for 10 years, or 4 packs/day for 5 years.
AND/OR;
2. Ten-year history of twenty orally-consumed alcohol units/week and is either a current
drinker or has quit drinking within the last 24 months. Twenty orally-consumed
alcohol units/week is defined as the equivalent of twenty - 1 ounce shots of whisky
or spirits/week (20 ounces = 600 mL), or twenty - 3 ounce glasses of wine/week (60
ounces = 1800 mL), or twenty - 12 ounce glasses of beer/week (240 ounces = 7200 mL);
3. Male or female, at least 45 years of age;
4. Written informed consent.
5. Females of childbearing potential may be enrolled following a negative urine
pregnancy test performed at the SE visit. Abstinence will be considered an acceptable
form of birth control.
Exclusion Criteria:
1. History of oral cancer, surgery or biopsy for suspected oral neoplasm;
2. History of recent oral surgery, periodontal treatment, or oral trauma (<14 days) or
current orthodonture (e.g., braces);
3. Known hypersensitivity to study drug or its analogs;
4. Active and uncontrolled infection or any other severe concurrent disease that in the
judgment of the investigator would make the patient inappropriate for entry into this
study;
5. Psychiatric disorders which would interfere with informed consent or follow-up;
6. Use of any investigational agent within previous 30 days;
7. Female that is lactating or demonstrating positive pregnancy test;
8. Patients in whom betel nut use/abuse has been reported within the past 5 years;
9. Patients currently taking medication containing prohibited dyes.
Age minimum:
45 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Head and Neck Cancer
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Oropharynx Cancer
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Intervention(s)
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Drug: OraTest
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Other: Visual Examination
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Primary Outcome(s)
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Ratio of Sensitivity of OraTest + Visual Exam Versus Sensitivity of Visual Exam Alone
[Time Frame: Two (2) scheduled visits for visual examination.]
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Secondary ID(s)
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2005-1008
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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