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NCT00537199 · ClinicalTrials.gov registry record · Phase 3
OraTest in Combination With Visual Examination and Visual Examination Alone
A Phase 3 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1
- Enrollment target
NCT00537199: Clinical Trial Phase 3 study, sponsored by M.D. Anderson Cancer Center.
NCT00537199 is a Phase 3 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 1 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00537199, a Phase 3 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1 participants
- Enrollment target
Study Summary
Primary Objectives: 1. To assess the ratio in sensitivities of OraTest® in combination with visual examination versus visual examination alone in the detection of serious pathology defined as severe dysplasia, CIS, or cancer of the O/OP cavity in patients who are at high risk for squamous cell carcinoma, carcinoma in situ, or severe dysplasia of the oral/oropharyngeal (O/OP) cavity due to their age and lifestyle risk factors. 2. To estimate the adjusted specificity of OraTest® in combination with visual examination in the detection of severe dysplasia, CIS, or cancer of the O/OP cavity. Secondary Objectives: 1. To assess the ratio of sensitivity of OraTest® in combination with visual examination versus visual examination alone in the detection of certain chromosomal abnormalities (17p chromosomal deletions, or both 3p and 9p chromosomal deletions), severe dysplasia, CIS, or cancer of the O/OP cavity in patients who are at high risk for squamous cell carcinoma, carcinoma in situ, or severe dysplasia of the oral/oropharyngeal (O/OP) cavity due to their age and lifestyle risk factors. 2. To obtain the adjusted specificity of OraTest® in combination with visual examination in the detection of certain chromosomal abnormalities (17p chromosomal deletions, or both 3p and 9p chromosomal deletions), severe dysplasia, CIS or cancer of the O/OP cavity. 3. To evaluate the chromosomal status of the positively staining lesions with respect to 3p, 9p, or 17p deletions. 4. To carry out gene expression studies on biopsies and map these onto an analysis of the widespread chromosomal imbalances in stain-positive and stain-negative lesions. 5. To evaluate the quantitative and qualitative toxicities, as well as other safety parameters, of tolonium chloride 5 mg/mL (OraTest®).
Primary Outcome
Primary efficacy parameters, ratio of sensitivity of OraTest® in combination with visual exam versus visual exam alone is the difference between the adjusted specificity for OraTest in combination with visual exam and the adjusted specificity for visual exam alone. Reported ratio as percentage of patients with abnormalities (suspicious lesions) found upon visual exam of the mouth with and without OraTest® dye.
Interventions
- OTHER Visual Examination
- DRUG OraTest
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2006-11 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
Why NCT00537199 stopped before completion
NCT00537199 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Visual Examination is the first listed.
NCT00537199 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00537199 about?
NCT00537199 is a clinical study titled "OraTest in Combination With Visual Examination and Visual Examination Alone". Primary Objectives: 1. To assess the ratio in sensitivities of OraTest® in combination with visual examination versus visual examination alone in the detection of serious pathology defined as severe dysplasia, CIS, or cancer of the O/OP cavity in patients who are at high risk for squamous cell carc...
What is the current status of trial NCT00537199?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2006-11. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00537199?
The interventions under investigation include: Visual Examination (OTHER), OraTest (DRUG).
Who is sponsoring clinical trial NCT00537199?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00537199's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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