NCT03087695

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 6, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2019

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

10 months

First QC Date

March 6, 2017

Last Update Submit

March 16, 2017

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinomaEBV DNAChemoradiotherapy

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS)

    Survival calculation

    2 years

Secondary Outcomes (6)

  • Progression free survival (PFS)

    2 years

  • Nasopharynx failure-free survival (NPFFS)

    2 years

  • Neck failure-free survival (NFFS)

    2 years

  • Distant metastasis failure-free survival (DMFFS)

    2 years

  • Tumor response

    2 years

  • +1 more secondary outcomes

Interventions

Plasma EBV DNADIAGNOSTIC_TEST

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.

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Nasopharyngeal carcinoma patient received definite treatment in Taichung Veteran General Hospital

You may qualify if:

  • Histological proven NPC.
  • American Joint Committee on Cancer (AJCC) stage II-IVB.
  • Age ≧ 20 years old.
  • Performance status of Eastern Cooperative Oncology Group (ECOG) ≦ 2.
  • 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.
  • White blood cell count (WBC) ≧ 3,000/micro-ml. 5.4 Platelet count ≧ 100,000/micro-ml.
  • Pre-treatment plasma EBV DNA \> 0 copies/mL
  • Signed informed consent.

You may not qualify if:

  • Presence of distant metastasis.
  • Previous radiotherapy or chemotherapy.
  • 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.
  • 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.
  • Female patients who are pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veteran General Hospital

Taichung, 40705, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The patients will be collected blood sample once per week during chemoradiotherapy period. Plasma will be extracted from these blood sample. Plasma EBV DNA concentrations will be measured by a real-time quantitative polymerase chain reaction.

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Jin-Ching Lin, MD, PhD

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin-Ching Lin, MD, PhD

CONTACT

+886-4-23592525jclin@vghtc.gov.tw

Yi-Chun Liu, MD

CONTACT

+886-4-23592525b9202080@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 22, 2017

Study Start

April 1, 2017

Primary Completion

January 16, 2018

Study Completion

January 16, 2019

Last Updated

March 22, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

No plan to make individual participant data (IPD) available

Locations

TW(1)