NCT02505139

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 29, 2016

Status Verified

August 1, 2016

Enrollment Period

1.6 years

First QC Date

July 20, 2015

Last Update Submit

August 25, 2016

Conditions

Nasopharyngeal Neoplasms

Keywords

nasopharyngeal carcinomadistant metastasiscirculating tumor cellsoutcome prediction

Outcome Measures

Primary Outcomes (1)

  • Overall survival rate

    3 years

Secondary Outcomes (4)

  • The proportion of positives that are correctly identified as such

    3 years

  • The proportion of negatives that are correctly identified as such

    3 years

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

    3 years

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

    3 years

Study Arms (1)

Study Group

Other: the number of circulating tumor cells

Interventions

the number of circulating tumor cellsOTHER
Study Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

NPC patients with distant metastasis

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 24888818RESULT

  • 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.

    PMID: 25474037RESULT

  • 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.

    PMID: 15735118RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

The blood after separation and purification along with or without CTC.

MeSH Terms

Conditions

Nasopharyngeal NeoplasmsNasopharyngeal CarcinomaNeoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ming-Yuan Chen, MD, PhD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

July 20, 2015

First Posted

July 22, 2015

Study Start

December 1, 2014

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

August 29, 2016

Record last verified: 2016-08