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

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

Recruiting
18-90 years
All
Phase N/A

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Overview

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.

Description

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.

Eligibility

Inclusion Criteria:

Participants with Cancer:

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

Exclusion Criteria:

  1. Presence of psychiatric disorders.
  2. Deemed unsuitable for participation by the attending physician.
  3. Unwilling to participate in the study.

Study details
    Head and Neck Cancer
    Oral Cancer

NCT07296250

Chang Gung Memorial Hospital

1 February 2026

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