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

NCT ID: NCT02505139

Last Updated: 2016-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-08-31

Brief Summary

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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

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Conditions

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Nasopharyngeal Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group

the number of circulating tumor cells

Intervention Type OTHER

Interventions

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the number of circulating tumor cells

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Ming-Yuan Chen

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ming-Yuan Chen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

References

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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.

Reference Type RESULT
PMID: 24888818 (View on PubMed)

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.

Reference Type RESULT
PMID: 25474037 (View on PubMed)

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.

Reference Type RESULT
PMID: 15735118 (View on PubMed)

Other Identifiers

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SYSUCCCTC

Identifier Type: -

Identifier Source: org_study_id

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