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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | 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. | |
| experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-dose oral chemotherapy | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Circulating tumor cells (CTCs) testing | participants will undergo CTCs testing after completing concurrent Chemoradiotherapy (CCRT). If CTC-positive (≥5.0 cells/mL), participants will receive low-dose oral chemotherapy for three months, followed by repeat CTC testing. Persistent positivity will warrant continued treatment up to one year after curative surgery, while negativity will lead to treatment discontinuation. | baseline |
| Circulating tumor cells (CTCs) testing | participants will undergo CTCs testing after completing concurrent Chemoradiotherapy (CCRT). If CTC-positive (≥5.0 cells/mL), participants will receive low-dose oral chemotherapy for three months, followed by repeat CTC testing. Persistent positivity will warrant continued treatment up to one year after curative surgery, while negativity will lead to treatment discontinuation. | 3 month |
| Circulating tumor cells (CTCs) testing | participants will undergo CTCs testing after completing concurrent Chemoradiotherapy (CCRT). If CTC-positive (≥5.0 cells/mL), participants will receive low-dose oral chemotherapy for three months, followed by repeat CTC testing. Persistent positivity will warrant continued treatment up to one year after curative surgery, while negativity will lead to treatment discontinuation. | 6 month |
| Circulating tumor cells (CTCs) testing | participants will undergo CTCs testing after completing concurrent Chemoradiotherapy (CCRT). If CTC-positive (≥5.0 cells/mL), participants will receive low-dose oral chemotherapy for three months, followed by repeat CTC testing. Persistent positivity will warrant continued treatment up to one year after curative surgery, while negativity will lead to treatment discontinuation. | 9 month |
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Inclusion Criteria:
Participants with Cancer:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ChunTa Liao, PhD | Contact | 0975360141 | liaoct@cgmh.org.tw | |
| Chia-Hsun Hsieh, PhD | Contact | 0975366137 | wisdom5000@cgmh.org.tw |
| Name | Affiliation | Role |
|---|---|---|
| ChunTa Liao, PhD | Division of Otolaryngology, Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linkou Chang Gung Memorial Hospital | Recruiting | Taoyuan City | 333423 | Taiwan |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009062 | Mouth Neoplasms |
| D009360 | Neoplastic Cells, Circulating |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| D009362 |
| Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |