Clinical trial NCT02505139: The Value of Diagnosis and Outcome Prediction in CTC for Metastatic NPC Patients
Official title: Using Circulating Tumor Cells to Diagnose and Predict Prognosis in Metastatic Nasopharyngeal Carcinoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasopharyngeal Neoplasms
Keywords: nasopharyngeal carcinoma
distant metastasis
circulating tumor cells
outcome prediction
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NPC patients with distant metastasis

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.


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 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.

Primary outcomes:
measure: Overall survival rate
timeFrame: 3 years
Secondary outcomes:
measure: The proportion of positives that are correctly identified as such
timeFrame: 3 years
measure: The proportion of negatives that are correctly identified as such
timeFrame: 3 years
measure: The proportions of positive results in statistics and diagnostic tests that are true positive results.
timeFrame: 3 years
measure: The proportions of negative results in statistics and diagnostic tests that are true negative results.
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Sun Yat-sen University
name: Ming-Yuan Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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 S0500. J Clin Oncol. 2014 Nov 1;32(31):3483-9. doi: 10.1200/JCO.2014.56.2561. Epub 2014 Jun 2.
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-culture model. Oncotarget. 2014 Dec 15;5(23):12383-97. doi: 10.18632/oncotarget.2592.
citation: 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 Clin Oncol. 2005 Mar 1;23(7):1420-30. doi: 10.1200/JCO.2005.08.140.