Skip to main content
OpenTrials
Completed

NCT Number: NCT02505139

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nasopharyngeal Neoplasms Carcinoma Head and Neck Neoplasms Nasopharyngeal Carcinoma Nasopharyngeal Diseases Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Cells, Circulating Neoplastic Processes Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

the number of circulating tumor cells

Other

Primary outcomes

  1. Overall survival rate

    Time frame: 3 years

Secondary outcomes

  1. The proportion of positives that are correctly identified as such

    Time frame: 3 years

    number of true positives divided by (number of true positives plus number of false negatives)

  2. The proportion of negatives that are correctly identified as such

    Time frame: 3 years

    number of true negatives divided by (number of true negatives plus number of false positives)

  3. The proportions of positive results in statistics and diagnostic tests that are true positive results.

    Time frame: 3 years

    number of true positives divided by number of positive calls

  4. The proportions of negative results in statistics and diagnostic tests that are true negative results.

    Time frame: 3 years

    number of true negatives divided by number of negative calls

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 22, 2015
Registry last updated
Aug 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.