Health Condition 1: C01- Malignant neoplasm of base of tongue Health Condition 2: C021- Malignant neoplasm of border of tongue Health Condition 3: C03- Malignant neoplasm of gum
Conditions
Interventions
None listed
Sponsors
Vigilant Biosciences
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must meet all of the inclusion criteria to participate in this study. 1) Patient has the ability to understand and the willingness to sign a written informed consent. 2) Previously untreated, measurable squamous cell carcinoma of the oral cavity or oropharynx with no evidence of distant metastasis, T1-4N0-3M0 3) No prior history of treated upper aerodigestive tract cancer 4) No concurrent, second, active malignancy other than the oral cavity and/or oropharynx cancer 5) Planned to undergo treatment with curative intent 6) Able to follow up after therapy at 3, 6, 12, and 18 months after completion of therapy during routine post-treatment follow up 7) For control subjects: no evidence or history of upper aerodigestive tract cancer 8) For control subjects: absence of any suspected or confirmed active malignancy at the time of enrollment. 9) Patients may have had prior therapy for malignancy other than upper aerodigestive malignancy completed 2 years prior to enrollment if they have been disease free since completion of therapy 10) The patient or the healthy volunteer is more than or equal to 18 years of age. 11) Performance Status less than or equal to ECOG 3 12) The patient is able to gargle and spit 5 cc of saline 13) Patients may be concurrently enrolled in other therapeutic or detection clinical trials.
Exclusion criteria
Exclusion criteria: 1) Prior completed therapy for an upper aerodigestive tract cancer within the past 3 years. 2) Patient unable to gargle and spit 5 cc of saline, or anticipated to be unable to gargle and spit after completion of therapy 3) Patient unable or does not intend to undergo curative therapy 4) Patient with concurrent, second primary malignancy under active therapy or completed therapy within 2 years prior to enrollment. 5) Non-squamous histology
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity and specificity to detect OOPSCC in cases compared to a non-cancer control population. We anticipate that the POC test renders a sensitivity of at least 80% which is much higher than what is currently available, and therefore we consider a specificity of 0.65 minimally acceptable for the Vigilant POC test. In order to demonstrate a clinically acceptable level of specificity, a performance goal of 0.75 is chosen.Timepoint: At the completion of the study - 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The association of salivary test biomarkers with clinical characteristics of OOPSCC patients and patient overall and disease-free survival using univariate and multivariate analyses. 2. The association of post-treatment SolCD44 and Total Protein with recurrence and determine the magnitude of that association. 3. Preliminary estimates of possible lead time if SolCD44 / Total Protein elevation precedes recurrence. Timepoint: At the completion of the study - 24 months | — |
Countries
India
Contacts
Public ContactDr Sudhir V Nair
Tata Memorial Centre
Outcome results
None listed