A prospective, pilot evaluation of a point of care saliva-based detection test based on soluble CD44 (OncAlert) for the presence of disease in a previously untreated oral cavity and oropharynx squamous cell carcinoma.

Vigilant Biosciences0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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

发起方

Vigilant Biosciences