Идёт набор NCT06174428

Validity of Viome's Oral/throat Cancer Test

— Наблюдательное Oral and Throat Cancer Oropharyngeal Squamous Cell Carcinoma Oral Squamous Cell Carcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Oral/Throat cancer test.
Кому может быть актуально: Состояния в реестре: Oral and Throat Cancer, Oropharyngeal Squamous Cell Carcinoma, Oral Squamous Cell Carcinoma. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Validity of Viome's Oral/throat Cancer Test Among Patients with a Suspicion of Cancer

Обзор

A total of at least 1,000 participants with suspicion of cancer including at least 107 subjects who will be diagnosed with OSCC or OPSCC will be enrolled from either primary or secondary care centers in the U.S. Clinicians will use Viome collection kits to collect saliva samples from eligible patients.

Подробное описание

This is a prospective, multi-center study. Subjects with OSCC or OPSCC will be enrolled from four primary and secondary care centers in the U.S. Study samples will be collected by the clinicians at the study sites using Viome saliva sample collection kits. Patients will continue with their current health plan and confirm diagnosis following the standard of care of surgical biopsy with histology if needed. If a biopsy is performed, the result of the biopsy will be compared with the result of the Viome kit. If no biopsy is performed, the Viome test result will be compared with the physician's assessment based on clinical judgment. Patients with a positive result from histology will not receive the results of the Viome kit, and it will not play any part in the clinical management of the patients.

Вмешательства

Устройство Oral/Throat cancer test
The Oral/Throat cancer test is intended for the qualitative detection of molecular features (human genes, microbial species and functions) associated with Oral Squamous Cell Carcinoma (OSCC) or OroPharyngeal Squamous Cell Carcinoma (OPSCC) in saliva samples from adults with a suspicion of cancer. A positive result from CDOT may indicate the presence of OSCC or OPSCC. The device is intended as a diagnostic aid for clinicians when assessing patients with suspected OSCC or OPSCC who may benefit fro

Первичные конечные точки

Sensitivity [Срок оценки: Through study completion, an average of 18 months]
Specificity [Срок оценки: Through study completion, an average of 18 months]
Positive Post Test Probability (PPV) [Срок оценки: Through study completion, an average of 18 months]
Negative Post Test Probability (NPV) [Срок оценки: Through study completion, an average of 18 months]

Вторичные конечные точки (12)

Sensitivity by care center (primary and secondary) [Срок оценки: Through study completion, an average of 18 months]
Sensitivity by age [Срок оценки: Through study completion, an average of 18 months]
Sensitivity by sex [Срок оценки: Through study completion, an average of 18 months]
Sensitivity by race [Срок оценки: Through study completion, an average of 18 months]
Sensitivity by smoking history [Срок оценки: Through study completion, an average of 18 months]
Sensitivity by oral cancer type (OSCC or OPSCC) [Срок оценки: Through study completion, an average of 18 months]
Sensitivity by disease stage (I, II, III, and IV) [Срок оценки: Through study completion, an average of 18 months]
Sensitivity by metastasis [Срок оценки: Through study completion, an average of 18 months]
Sensitivity by HPV status [Срок оценки: Through study completion, an average of 18 months]
Sensitivity by recurrent cancer [Срок оценки: Through study completion, an average of 18 months]
Specificity by care center (primary and secondary) [Срок оценки: Through study completion, an average of 18 months]
Specificity by age [Срок оценки: Through study completion, an average of 18 months]

Критерии участия

Критерии включения

Signed and dated informed consent prior to any study-specific procedures are performed
Willing and able to follow the study instructions, as described in the recruitment letter
Adults (18 years old or older)
Suspicion of OSCC or OPSCC on clinical presentation by a clinician