Clinical trial · Observational
CytID Analysis of Oral Lesions
NCT03555721CI-TRIAL-00066315terminatedClinicalTrials.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): low subject recruitment
Summary
Brief summary (as posted)
The purpose of this study is to correlate the results from a standard of care biopsy with CytID™ and hpvID™ swab tests for potentially premalignant and malignant oral lesions. The biopsy is considered standard of care and will be performed regardless of the patient's enrollment in the study. The study-related data gathering will not influence the treatment decisions of the clinician.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cavity Cancer | Malignant Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Diagnostic Test | — | UNRESOLVED |
| CytID | Diagnostic Test | — | UNRESOLVED |
| hpvID | Diagnostic Test | — | UNRESOLVED |
| Oral examination with incandescent light | Other | — | UNRESOLVED |
| Oral examination with OralID | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Oral examination followed by biopsy, CytID, and hpvID
- description
- Identification of oral lesions with oral examination with both incandescent light and fluorescent light (OralID), and subsequent testing of suspicious oral lesions with biopsy, CytID, and hpvID
- interventionNames
- Other: Oral examination with incandescent light
- Other: Oral examination with OralID
- Diagnostic Test: Biopsy
- Diagnostic Test: CytID
- Diagnostic Test: hpvID
Primary outcomes (6)
- measure
- Number of participants for whom biopsy and CytID results both indicate presence of malignant or premalignant oral lesions
- timeFrame
- day 1 (at the time of oral examination)
- measure
- Number of participants for whom biopsy indicates presence of malignant or premalignant oral lesions and hpvID indicates presence of HPV
- timeFrame
- day 1 (at the time of oral examination)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Receive care at the Avenue 360 Health and Wellness Clinic, a not for profit dental clinic in the Montrose area of Houston * Present with a potentially malignant oral lesion (PMOL) for whom a biopsy is deemed necessary Exclusion Criteria: * Do not receive care at the Avenue 360 Health and Wellness Clinic, a not for profit dental clinic in the Montrose area of Houston * Do not present with a potentially malignant oral lesion (PMOL) for whom a biopsy is deemed necessary
References
Publications (0)
Data not yet available
No reference posted for this study.