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

Nasopharyngeal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02505139
• Other study ID #: SYSUCCCTC
• Status: Completed
• Phase: N/A
• First received: July 20, 2015
• Last updated: August 25, 2016
• Start date: December 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Nasopharyngeal Neoplasms
• Neoplastic Cells, Circulating

Intervention

Other:
• the number of circulating tumor cells

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

References & Publications (3)

Cristofanilli M, Hayes DF, Budd GT, Ellis MJ, Stopeck A, Reuben JM, Doyle GV, Matera J, Allard WJ, Miller MC, Fritsche HA, Hortobagyi GN, Terstappen LW. Circulating tumor cells: a novel prognostic factor for newly diagnosed metastatic breast cancer. J Cli — View Citation

Smerage JB, Barlow WE, Hortobagyi GN, Winer EP, Leyland-Jones B, Srkalovic G, Tejwani S, Schott AF, O'Rourke MA, Lew DL, Doyle GV, Gralow JR, Livingston RB, Hayes DF. Circulating tumor cells and response to chemotherapy in metastatic breast cancer: SWOG S — View Citation

Zhang Z, Shiratsuchi H, Lin J, Chen G, Reddy RM, Azizi E, Fouladdel S, Chang AC, Lin L, Jiang H, Waghray M, Luker G, Simeone DM, Wicha MS, Beer DG, Ramnath N, Nagrath S. Expansion of CTCs from early stage lung cancer patients using a microfluidic co-cultu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate		3 years	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No