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Status unknownNCT03087695Updated Mar 22, 2017

Effect of the Plasma EBV DNA Change During Chemoradiotherapy in Nasopharyngeal Carcinoma

An observational study in Nasopharyngeal Carcinoma, sponsored by Taichung Veterans General Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-03-22.

Sponsored by Taichung Veterans General Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
20 Years and older
Sex
All
01

Study summary

Epstein-Barr virus (EBV) has been proven to process a strong association in patient of nasopharyngeal carcinoma (NPC). Monitoring plasma EBV DNA in NPC patients can provide reliable informations in early detecting tumor recurrence or risk grouping.

Read the detailed description

EBV DNA has strongly association in NPC patient' disease status. It can provide informations of disease relapse or risks classification. In this study, we will investigate the impact of plasma EBV DNA concentration change during chemoradiotherapy on initial tumor response and long-term survival in patients with advanced nasopharyngeal carcinoma

02

Conditions studied

  • Nasopharyngeal Carcinoma

Keywords

  • Nasopharyngeal carcinoma
  • EBV DNA
  • Chemoradiotherapy
03

In context

Carcinoma

6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's planned enrollment of 200 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Taichung Veterans General Hospital is the lead sponsor of 170 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Nasopharyngeal carcinoma patient received definite treatment in Taichung Veteran General Hospital

Inclusion criteria

  1. Histological proven NPC.
  2. 2010 American Joint Committee on Cancer (AJCC) stage II-IVB.
  3. Age ≧ 20 years old.
  4. Performance status of Eastern Cooperative Oncology Group (ECOG) ≦ 2.

  5. Adequate liver, renal, and bone marrow functions 5.1 Serum total bilirubin level ≦ 2.5 mg/dl. 5.2 Serum creatinine ≦ 1.6 mg/dl or calculated creatinine clearance rate (CCr) ≧ 60 cc/min.

    5.3 White blood cell count (WBC) ≧ 3,000/micro-ml. 5.4 Platelet count ≧ 100,000/micro-ml.

  6. Pre-treatment plasma EBV DNA > 0 copies/mL
  7. Signed informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Presence of distant metastasis.
  2. Previous radiotherapy or chemotherapy.
  3. History of a malignancy except those treated with curative intent for skin cancer (other than melanoma), in situ cervical cancer, ductal carcinoma in situ (DCIS) of the breast.
  4. Severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders.
  5. Female patients who are pregnant or lactating.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • Diagnostic testPlasma EBV DNA

    Parameters analyzed will include (1) the change pattern of plasma EBV DNA concentrations, (2) various half-life values (t1/2) of plasma EBV DNA clearance rate calculated over different time periods.

06

What researchers measure

Primary outcomes

  1. Overall survival (OS)

    Survival calculation

    Time frame: 2 years

Secondary outcomes

  1. Progression free survival (PFS)

    Survival calculation

    Time frame: 2 years

  2. Nasopharynx failure-free survival (NPFFS)

    Survival calculation

    Time frame: 2 years

  3. Neck failure-free survival (NFFS)

    Survival calculation

    Time frame: 2 years

  4. Distant metastasis failure-free survival (DMFFS)

    Survival calculation

    Time frame: 2 years

  5. Tumor response

    Tumor response evaluated by image

    Time frame: 2 years

  6. EBV DNA concentration

    Plasma EBV DNA by real-time polymerase chain reaction (PCR)

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Taichung Veteran General Hospital
    Taichung, 40705, Taiwan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — No plan to make individual participant data (IPD) available

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03087695
Lead sponsor
Taichung Veterans General Hospital
Responsible party
Sponsor
First posted
Mar 22, 2017
Start date
Apr 1, 2017 (estimated)
Primary completion
Jan 16, 2018 (estimated)
Completion
Jan 16, 2019 (estimated)
Last update
Mar 22, 2017

Study contacts

Jin-Ching Lin, MD, PhD
Contact
jclin@vghtc.gov.tw
+886-4-23592525 ext. 5613
Yi-Chun Liu, MD
Contact
b9202080@gmail.com
+886-4-23592525 ext. 5621
Jin-Ching Lin, MD, PhD
principal investigator · Taichung Veterans General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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