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Clinical Trials/NCT02505139
NCT02505139
Completed
Not Applicable

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

Sun Yat-sen University0 sites166 target enrollmentDecember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nasopharyngeal Neoplasms
Sponsor
Sun Yat-sen University
Enrollment
166
Primary Endpoint
Overall survival rate
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
August 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Ming-Yuan Chen

Prof.

Sun Yat-sen University

Eligibility Criteria

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
  • 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.

Outcomes

Primary Outcomes

Overall survival rate

Time Frame: 3 years

Secondary Outcomes

  • The proportions of positive results in statistics and diagnostic tests that are true positive results.(3 years)
  • The proportions of negative results in statistics and diagnostic tests that are true negative results.(3 years)
  • The proportion of positives that are correctly identified as such(3 years)
  • The proportion of negatives that are correctly identified as such(3 years)

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