Clinical trial · Observational
Developing an In-vitro Diagnostic Risk-Stratification Test for Oral Cancer
Pivotal Validation Study of Salivary Biomarkers for the Risk Stratification of Patients With Lesions Suspicious for Oral Squamous Cell Carcinoma
NCT01587573CI-TRIAL-00032496unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to verify the discriminatory value of previously identified salivary transcriptome and proteome markers for oral squamous cell cancer in an intended use population of patients with oral lesions suspicious for cancer.
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 |
|---|---|---|---|
| Oral Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| saliva collection prior to clinically driven oral biopsy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- oral lesions
- description
- oral lesions suspicious for squamous cell carcinoma with saliva collection prior to clinically driven oral biopsy
- interventionNames
- Other: saliva collection prior to clinically driven oral biopsy
Primary outcomes (1)
- measure
- Test specificity at 90% sensitivity
- timeFrame
- at study completion as well as after model development following enrollment of the first 30 patents with cancer
- description
- Based on multimarker test score
Secondary outcomes (2)
- measure
- Validation of individual mRNA and protein markers
- timeFrame
- After enrollment of 30 patients with cancer
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients scheduled for biopsy of an oral lesion suspicious for squamous cell cancer Exclusion Criteria: * Patients with known prior oral malignancy in last 2 years or other cancer in last 5 years other than non melanoma skin cancer or with immune deficiency
References
Publications (1)
- DERIVEDMartin JL. Validation of Reference Genes for Oral Cancer Detection Panels in a Prospective Blinded Cohort. PLoS One. 2016 Jul 13;11(7):e0158462. doi: 10.1371/journal.pone.0158462. eCollection 2016. PMID 27411053