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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 : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Ying Sun, Sun Yat-sen University

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

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

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serial Epstein-Barr Virus DNA Surveillance During Treatment in Non-metastatic Nasopharyngeal Carcinoma Patients
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : May 10, 2022
Estimated Study Completion Date : May 1, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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].



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

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): NCT03855020


Contacts
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Contact: Ying Sun, M.D. +86 87342253 sunying@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Ying Sun, M.D.    +86-020- 87343816    sunying@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University

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Responsible Party: Ying Sun, Vice-president, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03855020     History of Changes
Other Study ID Numbers: 2019-FXY-015-radiation
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (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

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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 Ying Sun, Sun Yat-sen University:
plasma EBV DNA
nasopharyngeal carcinoma
longitudinal surveillance
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