NCT02505139CompletedNot Applicable
Using Circulating Tumor Cells to Diagnose and Predict Prognosis in Metastatic Nasopharyngeal Carcinoma Patients
Sun Yat-sen University0 sites166 target enrollmentStarted: December 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 166
- Primary Endpoint
- Overall survival rate
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Ming-Yuan Chen
Prof.
Sun Yat-sen University
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