Идёт набор NCT07296250

Circulating Tumor Cell Counts in Postoperative ENE-Positive Oral Cavity Cancer Patients After Adjuvant CCRT

Без фазы С лечением Head and Neck Cancer Oral Cancer

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: low-dose oral chemotherapy.
Кому может быть актуально: Состояния в реестре: Head and Neck Cancer, Oral Cancer. Базовые параметры: 18 мес. — 90 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: Тайвань
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

A Randomized, Prospective Phase II Clinical Trial - Extended Chemotherapy or Not Based on Circulating Tumor Cell Counts in Postoperative ENE-Positive Oral Cavity Cancer Patients After Completing Adjuvant Concurrent Chemoradiotherapy

Обзор

The aim 1 of this trial is the development of the Circulating tumor cells (CTCs) definition of oral cancer minimal residual disease (MRD), and aim 2 is a prospective trial of oral cancer treatment. If this trial is successful, it is expected that it may be able to provide a standard diagnostic tool (MRD in Oral Cavity Squamous Cell Carcinoma (OCSCC)) and treatment mode (extended adjuvant chemotherapy with low-dose oral chemotherapy). The survival rate of patients will be improved.

Подробное описание

The aim 1 of this trial is the development of the CTC definition of oral cancer MRD, and aim 2 is a prospective trial of oral cancer treatment. If this trial is successful, it is expected that it may be able to provide a standard diagnostic tool (MRD in OCSCC) and treatment mode (extended adjuvant chemotherapy with low-dose oral chemotherapy). The survival rate of patients will be improved.

This three-year study is expected to recruit 100 oral cavity cancer patients with extracapsular nodal extension (ENE) or other postoperative risks.10 mL of research blood was drawn four times in total.Each patient must continue to be tracked for ENE or other postoperative risks for one year, and with blood testing every tree month.

For the negative selection of CTCs by the negative selection system. For the positive selection of CTCs by counting Epithelial cell adhesion molecule(EpCAM)-positive and Hoechst-positive cells under a microscope with a hemocytometer.

In brief, CTC could predict a poor prognosis in HNSCC patients. But the role of longitudinal CTC follow-up in ENE+ oral cavity cancer patients remains unclear.

Вмешательства

Процедура low-dose oral chemotherapy
recruit 100 oral cavity cancer patients with ENE or other postoperative risks.10 mL of research blood was drawn four times in total.Each patient must continue to be tracked for ENE or other postoperative risks for one year, and with blood testing every tree month.

Первичные конечные точки

Circulating tumor cells (CTCs) testing [Срок оценки: baseline]
Circulating tumor cells (CTCs) testing [Срок оценки: 3 month]
Circulating tumor cells (CTCs) testing [Срок оценки: 6 month]
Circulating tumor cells (CTCs) testing [Срок оценки: 9 month]

Критерии участия

Критерии включения

Participants with Cancer:

Aged between 18 and 90 years.
Histologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC).
Completed surgical treatment and identified as having high-risk factors, followed by concurrent chemoradiotherapy.
Willing to continue follow-up visits at the hospital after completion of treatment.