Nasopharyngeal CarcinomaNCT03087695
Effect of the Plasma EBV DNA Change During Chemoradiotherapy in Nasopharyngeal Carcinoma
An observational study of Nasopharyngeal Carcinoma, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Plasma EBV DNA
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2017to 16 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Adult, Older adult
Study population: Nasopharyngeal carcinoma patient received definite treatment in Taichung Veteran General Hospital
Who may be able to join
- Histological proven NPC.
- 2010 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.
- 5.3 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veteran General Hospital
Taichung, 40705
Jin-Ching Lin, MD, PhD, +886-4-23592525 ext. 5613, jclin@vghtc.gov.tw
Yi-Chun Liu, MD, +886-4-23592525 ext. 5621, b9202080@gmil.com
About this study
Official title: Effect of the Plasma EBV DNA Concentration Change During Chemoradiotherapy on Tumor Control and Patient Survival in Advanced Nasopharyngeal Carcinoma
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.
Read the 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
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Plasma EBV DNA
- Keywords
- Nasopharyngeal carcinoma, EBV DNA, Chemoradiotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Survival calculation
Measured: 2 years
Secondary outcomes (6)
Progression free survival (PFS)
Survival calculation
Measured: 2 years
Nasopharynx failure-free survival (NPFFS)
Survival calculation
Measured: 2 years
Neck failure-free survival (NFFS)
Survival calculation
Measured: 2 years
Distant metastasis failure-free survival (DMFFS)
Survival calculation
Measured: 2 years
Tumor response
Tumor response evaluated by image
Measured: 2 years
EBV DNA concentration
Plasma EBV DNA by real-time polymerase chain reaction (PCR)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start1 Apr 2017 (estimated)
- Primary completion16 Jan 2018 (estimated)
- Study completion16 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin-Ching Lin, MD, PhD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087695
- Sponsor's protocol ID
- CF17002B
- Status last verified
- Mar 2017
- First submitted
- 6 Mar 2017
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make individual participant data (IPD) available
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Plasma EBV DNA Concentration Change During Chemoradiotherapy on Tumor Control and Patient Survival in Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT03087695
- Acronym / sponsor ID
- CF17002B
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal carcinoma, EBV DNA, Chemoradiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (estimated)
- Primary completion
- 16 Jan 2018 (estimated)
- Study completion
- 16 Jan 2019 (estimated)
- First posted
- 22 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Nasopharyngeal carcinoma patient received definite treatment in Taichung Veteran General Hospital
Key inclusion criteria (8 listed)
- Histological proven NPC.
- 2010 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma EBV DNAParameters 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. | Diagnostic test | – |
Primary outcome
Overall survival (OS)
Time frame: 2 years
Survival calculation
6 secondary outcomes
Progression free survival (PFS)
Time frame: 2 years
Nasopharynx failure-free survival (NPFFS)
Time frame: 2 years
Neck failure-free survival (NFFS)
Time frame: 2 years
Distant metastasis failure-free survival (DMFFS)
Time frame: 2 years
Tumor response
Time frame: 2 years
EBV DNA concentration
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Individual participant dataSharing planned: No. No plan to make individual participant data (IPD) available
Related trials for Nasopharyngeal Carcinoma
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Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
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Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
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Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
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VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Ching Lin, MD, PhD principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin-Ching Lin, MD, PhD (+886-4-23592525 ext. 5613, jclin@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.