The Value of Diagnosis and Outcome Prediction in CTC for Metastatic NPC Patients

Study Overview
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Brief Summary
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A circulating tumor cell (CTC) count is an established prognostic factor in some malignancies such as metastatic breast cancer. However, the value of CTC in diagnosis and outcome prediction of metastatic nasopharyngeal carcinoma (mNPC) patients is not unknown. Through the observational prospective clinical trial, sensitivity, specificity, positive and negative predictive values of CTC in diagnosis of mNPC patients will be gained. Further, the value of CTC in outcome prediction of mNPC patients will be uncovered.

Official Title
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Using Circulating Tumor Cells to Diagnose and Predict Prognosis in Metastatic Nasopharyngeal Carcinoma Patients

Conditions
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Nasopharyngeal Neoplasms

Intervention / Treatment
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* Other: the number of circulating tumor cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or radiologically confirmed nasopharyngeal non-keratinizing carcinoma (WHO II, III). NPC patients with distant metastasis including synchronous distant metastasis at diagnosis and metachronous distant metastasis after radical treatment. A Karnofsky performance status score more than 70. The participants provided written informed consent. Exclusion Criteria: A history of previous or synchronous malignant tumors. Suffering from severe mental illness synchronously. Suffering from severe heart or lung diseases. Obvious abnormality in liver and renal function. Women in pregnancy or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br> | Other: the number of circulating tumor cells<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of positives that are correctly identified as such | number of true positives divided by (number of true positives plus number of false negatives) | 3 years | 
| The proportion of negatives that are correctly identified as such | number of true negatives divided by (number of true negatives plus number of false positives) | 3 years | 
| The proportions of positive results in statistics and diagnostic tests that are true positive results. | number of true positives divided by number of positive calls | 3 years | 
| The proportions of negative results in statistics and diagnostic tests that are true negative results. | number of true negatives divided by number of negative calls | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasopharyngeal carcinoma, distant metastasis, circulating tumor cells, outcome prediction