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This clinical research aims to explore potential biomarkers and validate molecular signatures' predictive and prognostic value in nasopharyngeal carcinoma.
Primary endpoint: Evaluation of the major pathological response of nasopharyngeal carcinoma patients.
Secondary endpoint: Evaluation of failure-free survival and overall survival of nasopharyngeal carcinoma patients.
Outline: This is a prospective observational study. Patients of nasopharyngeal carcinoma undergo inductive chemotherapy and concurrent chemoradiotherapy. Whole blood is obtained from patients when recruited, completing 10, 20, 32 fractions of radiation therapy, 3 months after radiation therapy and disease progression. Tumor tissue specimens are obtained from patients when recruited and disease progression. The samples are analyzed for biomarkers and spatial transcriptomics. The biomarkers and spatial transcriptomics are correlated with clinical outcomes (major pathological response, progression-free survival, overall survival, tumor response to treatment, distant metastasis, recurrence and death).
The analysis aims to explore potential biomarkers and validate molecular signatures' predictive and prognostic value in nasopharyngeal carcinoma. This will lead to the definition of risk groups and stratification of patients and will help in precision medicine of nasopharyngeal carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensity modulated radiation therapy (IMRT) combined with chemotherapy | Radiation | Intensity modulated radiation therapy (IMRT) combined with chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| major pathological response | 3 months after radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | 2 years after radiation therapy | |
| Overall Survival | 2 years after radiation therapy |
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Inclusion Criteria:
Exclusion Criteria:
Treatment with palliative intent
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Patients with newly histologically confirmed stage IVa nasopharyngeal carcinoma
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lirong Wu | Contact | +86-13701588737 | wulirong126@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Cancer Hospital | Nanjing | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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Whole blood is obtained from patients when recruited, completing 10, 20, 32 fractions of radiation therapy, 3 months after radiation therapy and disease progression. Tumor tissue specimens are obtained from patients when recruited and disease progression.
|
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |