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

Completed

• Conditions: Nasopharyngeal Neoplasms
• Interventions: Other: the number of circulating tumor cells

• Registration Number: NCT02505139
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-07-20
• Study First Submitted QC: 2015-07-21
• Study First Posted: 2015-07-22
• Primary Completion: 2016-07
• Status Verified: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-25
• Last Update Posted: 2016-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	the number of circulating tumor cells	-

Primary Outcome Measures

Name	Time	Method
Overall survival rate	3 years

Secondary Outcome Measures

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