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Serial Epstein-Barr Virus DNA Surveillance in Nasopharyngeal Carcinoma Patients

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ClinicalTrials.gov Identifier: NCT03855020
Recruitment Status : Recruiting
First Posted : February 26, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Ying Sun, Sun Yat-sen University

Tracking Information
First Submitted Date February 21, 2019
First Posted Date February 26, 2019
Last Update Posted Date May 14, 2019
Estimated Study Start Date May 9, 2019
Estimated Primary Completion Date May 10, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 23, 2019)
Progression-free survival [ Time Frame: 3 years ]
Progression-free survival is calculated from the date of diagnosis of NPC to the date of progression of NPC or the date of death from any cause, whichever comes earlier.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03855020 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 23, 2019)
  • overall survival [ Time Frame: 3 years ]
    Overall survival is calculated from the date of diagnosis of NPC to the date of death from any cause
  • Distant metastasis-free survival [ Time Frame: 3 years ]
    Distant metastasis-free survival is calculated from the date of diagnosis of NPC to the date of distant metastasis or date of death from any cause, whichever comes earlier.
  • locoregional failure-free survival [ Time Frame: 3 years ]
    Local or regional failure-free survival is calculated from the date of diagnosis of NPC to the date of regional nodal failure or date of death from any cause, whichever comes earlier.
  • EBV DNA clearance rate [ Time Frame: during the first month ]
    The half-life value (t1/2) of plasma EBV DNA clearance was calculated using the equation of [t1/2 = 0.693/k].
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Serial Epstein-Barr Virus DNA Surveillance in Nasopharyngeal Carcinoma Patients
Official Title Serial Epstein-Barr Virus DNA Surveillance During Treatment in Non-metastatic Nasopharyngeal Carcinoma Patients
Brief Summary Endemic nasopharyngeal carcinoma (NPC) is invariably associated with Epstein-barr virus (EBV) infection. Plasma EBV DAN detected by polymerase chain reaction (PCR)-based assays can provide important informations of disease screening, disease relapse, and risks classification. In this study, the investigators will explore the impact of serial plasma EBV DNA during chemotherapy and radiotherapy on initial tumor response and long-term survival in patients with non-metastatic nasopharyngeal carcinoma
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with histologically confirmed, non-metastatic, previously untreated nasopharyngeal carcinoma (NPC) will be invited to join this study.
Condition Nasopharyngeal Carcinoma
Intervention Diagnostic Test: Plasma EBV DNA
Parameters analyzed will include (1) the changing pattern of plasma EBV DNA concentrations during chemotherapy and radiotherapy (2) half-life values (t1/2) of plasma EBV DNA clearance rate
Study Groups/Cohorts observational cohort
Patients enrolled in this observational cohort would have regular blood taking for EBV DNA examination at baseline, after every cycle of chemotherapy, every week during radiotherapy, and 1-3 months after chemo-radiotherapy until EBV DNA becomes undetectable for at least two times.
Intervention: Diagnostic Test: Plasma EBV DNA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 23, 2019)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 1, 2024
Estimated Primary Completion Date May 10, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patients with newly histologically confirmed non-keratinizing carcinoma (according to WHO histological type)
  2. No evidence of distant metastasis (M0)
  3. Receive standard radical treatment
  4. Not exhibiting overt psychopathology, and willing to participate and written informed consent was obtained

Exclusion Criteria:

  1. WHO type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
  2. Treatment with palliative intent
  3. Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
  4. Severe intercurrent disease
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ying Sun, M.D. +86 87342253 sunying@sysucc.org.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03855020
Other Study ID Numbers 2019-FXY-015-radiation
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: not to share individual participant data (IPD) available to other researchers unless reasonably required, and only the PI has the whole access to the complete data
Responsible Party Ying Sun, Sun Yat-sen University
Study Sponsor Sun Yat-sen University
Collaborators Not Provided
Investigators Not Provided
PRS Account Sun Yat-sen University
Verification Date May 2019