Clinical trial · Interventional
Diagnostic Aids for Detection and Diagnosis of Oral Cancer
Evaluation of Diagnostic Aids for Detection and Diagnosis of Oral Cancer
NCT02251639CI-TRIAL-00027227withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study design improvements.
Summary
Brief summary (as posted)
The goal of this clinical study is to find out if certain instruments/devices, such as wide field fluorescence imaging point spectroscopy and/or brush cytology, can help health care providers find mouth cancer more quickly than a standard oral clinical exam.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Brush Biopsy | Procedure | — | UNRESOLVED |
| POS + PS2 + VELscope | Device | — | UNRESOLVED |
| Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oral Imaging and Cytology
- description
- Participant completes a short questionnaire regarding their awareness of oral cancer and risk factors. Oral cavity inspected using a standard white light headlamp. Oral cavity then examined with one or more of the widefield imaging devices, such as the VELscope and/or PS2 device. Exfoliative cells for cytology from an abnormal area (if present) and from a contralateral normal appearing area obtained using a brush.
- interventionNames
- Behavioral: Questionnaire
- Device: POS + PS2 + VELscope
- Procedure: Oral Brush Biopsy
Primary outcomes (1)
- measure
- Performance of the POS, PS2 and VELscope as Diagnostic Aid for Oral Cancer
- timeFrame
- 1 day
- description
- Information obtained from the fluorescence and reflectance images, point spectroscopy, and oral cytology compared with clinical diagnosis to evaluate the performance of the diagnostic aids and assess any clinical benefit to assist in screening for oral cancer. ROC curve analysis used as primary method for evaluating the performance of the POS, PS2 and VELscope devices as compared to the white light standard clinical diagnosis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects 18 years and older who are willing to participate. 2. Persons presenting for: Physical or dental exams at outside health care centers OR Research meetings/gatherings OR Subjects identified at MDACC who are not already diagnosed with oral cancer or pre oral cancer: this includes patients with malignancies other than oral cancer, and visitors and family members, attendees of the HNS Oral Cancer Screening event who are willing to participate. Exclusion Criteria: 1. Subjects with a current diagnosis of oral cancer. 2. Subjects under the age of 18. It is extremely unusual for children to develop oral cancer, therefore data from persons younger than 18 may add unexpected variables which could affect data analysis. 3. Subjects who are unable or unwilling to give informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.