免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Plasma EBV DNA Monitoring in Post-treatment NPC Patients

Plasma EBV DNA Monitoring in Post-treatment NPC Patients

Study Description
Brief Summary:
Continuous regular monitoring of plasma EBV DNA in nasopharyngeal carcinoma (NPC) after treatment have rarely been investigated. The investigators try to analyze the long-term observational results (role in early relapse detection and impact on survival) in NPC patients after curative treatment.

Condition or disease
Nasopharyngeal Carcinoma NPC EBV Radiotherapy

Detailed Description:
The investigators enrolled 441 NPC patients who had finished finished curative radiotherapy with/without chemotherapy and no recurrence/metastasis before entry this study from five hospitals in Taiwan. Blood samples were collected on the day of enrollment and monitored once every 2-3 months for plasma EBV DNA measurement. After long-term observation, we analyze the impact of continuous plasma EBV DNA monitoring on the early dection of tumor relapse and do risk grouping for survival analyses according to the blood test results.
Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 441 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long-term Results of Plasma Epstein-Barr Virus DNA Monitoring In Nasopharyngeal Carcinoma After Curative Treatment
Actual Study Start Date : August 1, 2011
Actual Primary Completion Date : December 31, 2013
Actual Study Completion Date : April 30, 2019
Arms and Interventions
Group/Cohort
Patients with NPC after treatment
All patients with NPC without distant metastases who receiving adequate RT dose
Outcome Measures
Primary Outcome Measures :
  1. Time interval from the date of abnormal blood test to the date of clinically documented tumor relapse [ Time Frame: Five years ]
    From the end of treatment to any time when abnormal blood test is fund


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Five years ]
    Overall survival was calculated from the day of enrollment until death or the last follow-up visit

  2. Event-free survival (EFS) [ Time Frame: Five years ]
    Event-free survival was calculated from the day of enrollment until the date of first occurrence of tumor relapse (local, regional, or distant failures) or the last follow-up visit


Biospecimen Retention:   Samples With DNA
Blood and check plasma EBV DNA

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients with NPC who were treated at 5 hospitals (Taichung Veterans General Hospital, Taichung; Yuan's General Hospital, Kaohsiung; National Cheng Kung University Hospital, Tainan; Kaohsiung Medical University Hospital, Kaohsiung; Taipei Medical University Hospital, Taipei; Taiwan)
Criteria

Inclusion criteria

  • histologically-proven nasopharyngeal carcinoma without distant metastasis (M0) at initial presentation
  • finished curative radiotherapy (with/without chemotherapy) within 3 years

Exclusion criteria

  • no occurrence of documented recurrence/metastasis before entry
Contacts and Locations

Locations
Layout table for location information
Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan, 407
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jin-Ching Lin, M.D.,PhD Taichung Veterans General Hospital
Tracking Information
First Submitted Date June 3, 2019
First Posted Date June 4, 2019
Last Update Posted Date June 7, 2019
Actual Study Start Date August 1, 2011
Actual Primary Completion Date December 31, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 3, 2019) 		Time interval from the date of abnormal blood test to the date of clinically documented tumor relapse [ Time Frame: Five years ]
From the end of treatment to any time when abnormal blood test is fund
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 3, 2019)
  • Overall survival (OS) [ Time Frame: Five years ]
    Overall survival was calculated from the day of enrollment until death or the last follow-up visit
  • Event-free survival (EFS) [ Time Frame: Five years ]
    Event-free survival was calculated from the day of enrollment until the date of first occurrence of tumor relapse (local, regional, or distant failures) or the last follow-up visit
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 Plasma EBV DNA Monitoring in Post-treatment NPC Patients
Official Title Long-term Results of Plasma Epstein-Barr Virus DNA Monitoring In Nasopharyngeal Carcinoma After Curative Treatment
Brief Summary Continuous regular monitoring of plasma EBV DNA in nasopharyngeal carcinoma (NPC) after treatment have rarely been investigated. The investigators try to analyze the long-term observational results (role in early relapse detection and impact on survival) in NPC patients after curative treatment.
Detailed Description The investigators enrolled 441 NPC patients who had finished finished curative radiotherapy with/without chemotherapy and no recurrence/metastasis before entry this study from five hospitals in Taiwan. Blood samples were collected on the day of enrollment and monitored once every 2-3 months for plasma EBV DNA measurement. After long-term observation, we analyze the impact of continuous plasma EBV DNA monitoring on the early dection of tumor relapse and do risk grouping for survival analyses according to the blood test results.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood and check plasma EBV DNA
Sampling Method Probability Sample
Study Population The patients with NPC who were treated at 5 hospitals (Taichung Veterans General Hospital, Taichung; Yuan's General Hospital, Kaohsiung; National Cheng Kung University Hospital, Tainan; Kaohsiung Medical University Hospital, Kaohsiung; Taipei Medical University Hospital, Taipei; Taiwan)
Condition
  • Nasopharyngeal Carcinoma
  • NPC
  • EBV
  • Radiotherapy
Intervention Not Provided
Study Groups/Cohorts Patients with NPC after treatment
All patients with NPC without distant metastases who receiving adequate RT dose
Publications *
  • Lee AW, Poon YF, Foo W, Law SC, Cheung FK, Chan DK, Tung SY, Thaw M, Ho JH. Retrospective analysis of 5037 patients with nasopharyngeal carcinoma treated during 1976-1985: overall survival and patterns of failure. Int J Radiat Oncol Biol Phys. 1992;23(2):261-70.
  • Jiong L, Berrino F, Coebergh JW. Variation in survival for adults with nasopharyngeal cancer in Europe, 1978-1989. EUROCARE Working Group. Eur J Cancer. 1998 Dec;34(14 Spec No):2162-6.
  • Lin JC, Jan JS, Hsu CY, Jiang RS, Wang WY. Outpatient weekly neoadjuvant chemotherapy followed by radiotherapy for advanced nasopharyngeal carcinoma: high complete response and low toxicity rates. Br J Cancer. 2003 Jan 27;88(2):187-94. Review.
  • Lin JC, Jan JS, Hsu CY, Liang WM, Jiang RS, Wang WY. Phase III study of concurrent chemoradiotherapy versus radiotherapy alone for advanced nasopharyngeal carcinoma: positive effect on overall and progression-free survival. J Clin Oncol. 2003 Feb 15;21(4):631-7.
  • Lin JC, Jan JS, Chen KY, Hsu CY, Liang WM, Wang WY. Outpatient weekly 24-hour infusional adjuvant chemotherapy of cisplatin, 5-fluorouracil, and leucovorin for high-risk nasopharyngeal carcinoma. Head Neck. 2003 Jun;25(6):438-50.
  • Chan AT, Teo PM, Leung TW, Leung SF, Lee WY, Yeo W, Choi PH, Johnson PJ. A prospective randomized study of chemotherapy adjunctive to definitive radiotherapy in advanced nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 1995 Oct 15;33(3):569-77.
  • Cheng SH, Jian JJ, Tsai SY, Chan KY, Yen LK, Chu NM, Tan TD, Tsou MH, Huang AT. Prognostic features and treatment outcome in locoregionally advanced nasopharyngeal carcinoma following concurrent chemotherapy and radiotherapy. Int J Radiat Oncol Biol Phys. 1998 Jul 1;41(4):755-62.
  • International Nasopharynx Cancer Study Group; VUMCA I Trial. Preliminary results of a randomized trial comparing neoadjuvant chemotherapy (cisplatin, epirubicin, bleomycin) plus radiotherapy vs. radiotherapy alone in stage IV(> or = N2, M0) undifferentiated nasopharyngeal carcinoma: a positive effect on progression-free survival. Int J Radiat Oncol Biol Phys. 1996 Jun 1;35(3):463-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 3, 2019) 		441
Original Actual Enrollment Same as current
Actual Study Completion Date April 30, 2019
Actual Primary Completion Date December 31, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria

  • histologically-proven nasopharyngeal carcinoma without distant metastasis (M0) at initial presentation
  • finished curative radiotherapy (with/without chemotherapy) within 3 years

Exclusion criteria

  • no occurrence of documented recurrence/metastasis before entry
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03973723
Other Study ID Numbers CG11133
Has Data Monitoring Committee Yes
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
Responsible Party Taichung Veterans General Hospital
Study Sponsor Taichung Veterans General Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Jin-Ching Lin, M.D.,PhD Taichung Veterans General Hospital
PRS Account Taichung Veterans General Hospital
Verification Date June 2019

治疗医院

新药特效药

前沿医讯