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

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ClinicalTrials.gov Identifier: NCT03087695
Recruitment Status : Unknown
Verified March 2017 by Taichung Veterans General Hospital.
Recruitment status was:  Recruiting
First Posted : March 22, 2017
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Taichung Veterans General Hospital

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.

Condition or disease Intervention/treatment
Nasopharyngeal Carcinoma Diagnostic Test: Plasma EBV DNA

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

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of the Plasma EBV DNA Concentration Change During Chemoradiotherapy on Tumor Control and Patient Survival in Advanced Nasopharyngeal Carcinoma
Estimated Study Start Date : April 1, 2017
Estimated Primary Completion Date : January 16, 2018
Estimated Study Completion Date : January 16, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Plasma 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.


Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 2 years ]
    Survival calculation


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 2 years ]
    Survival calculation

  2. Nasopharynx failure-free survival (NPFFS) [ Time Frame: 2 years ]
    Survival calculation

  3. Neck failure-free survival (NFFS) [ Time Frame: 2 years ]
    Survival calculation

  4. Distant metastasis failure-free survival (DMFFS) [ Time Frame: 2 years ]
    Survival calculation

  5. Tumor response [ Time Frame: 2 years ]
    Tumor response evaluated by image

  6. EBV DNA concentration [ Time Frame: 2 years ]
    Plasma EBV DNA by real-time polymerase chain reaction (PCR)


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.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Nasopharyngeal carcinoma patient received definite treatment in Taichung Veteran General Hospital
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03087695


Contacts
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Contact: Jin-Ching Lin, MD, PhD +886-4-23592525 ext 5613 jclin@vghtc.gov.tw
Contact: Yi-Chun Liu, MD +886-4-23592525 ext 5621 b9202080@gmail.com

Locations
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Taiwan
Taichung Veteran General Hospital Recruiting
Taichung, Taiwan, 40705
Contact: Jin-Ching Lin, MD, PhD    +886-4-23592525 ext 5613    jclin@vghtc.gov.tw   
Contact: Yi-Chun Liu, MD    +886-4-23592525 ext 5621    b9202080@gmil.com   
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
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Principal Investigator: Jin-Ching Lin, MD, PhD Taichung Veterans General Hospital

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Responsible Party: Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT03087695     History of Changes
Other Study ID Numbers: CF17002B
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to make individual participant data (IPD) available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taichung Veterans General Hospital:
Nasopharyngeal carcinoma
EBV DNA
Chemoradiotherapy

Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases