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

NCT ID: NCT07296250

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2028-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Head and Neck Cancer Oral Cancer

Keywords

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oral cancer ENE Circulating tumor cells Adjuvant concurrent Chemoradiation, adjuvant CCRT Circulating tumor microemboli (CTM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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control

participants without low-dose oral chemotherapy. Each patient must continue to be tracked for ENE or other postoperative risks for one year, and with blood testing every tree month.

Group Type NO_INTERVENTION

No interventions assigned to this group

experimental

participants with low-dose oral chemotherapy. Each patient must continue to be tracked for ENE or other postoperative risks for one year, and with blood testing every tree month.

Group Type EXPERIMENTAL

low-dose oral chemotherapy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Months

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chun-Ta Liao

Professor Attending Physicians

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ChunTa Liao, PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Otolaryngology, Chang Gung Memorial Hospital

Locations

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Linkou Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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ChunTa Liao, PhD

Role: CONTACT

Phone: 0975360141

Email: [email protected]

Chia-Hsun Hsieh, PhD

Role: CONTACT

Phone: 0975366137

Email: [email protected]

Facility Contacts

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ChunTa Liao, PhD

Role: primary

ChiaHsun Hsieh, PhD

Role: backup

Other Identifiers

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202402125B0

Identifier Type: -

Identifier Source: org_study_id