Actively Recruiting
Sequencing-based Counting of Plasma Epstein-Barr Virus DNA in Non-metastatic Nasopharyngeal Carcinoma
Led by Hunan Cancer Hospital · Updated on 2024-03-20
50
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The investigators aim to explore a new EBV DNA surveillance method with both high sensitivity and specificity in nasopharyngeal carcinoma (NPC) patients. the investigators aim to conduct plasma EBV DNA counting by next generation sequencing (NGS) in non-metastatic NPC patients on their diagnose, after two cycles of induction chemotherapy (IC), and 4-8 weeks after definitive radiotherapy. The investigators aim to explore whether sequencing-based counting is better than PCR analysis in plasma EBV-DNA surveillance, so as to monitoring tumor responses to treatment and for guiding individualized treatment adaptation in the future.
CONDITIONS
Official Title
Sequencing-based Counting of Plasma Epstein-Barr Virus DNA in Non-metastatic Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed, pathologically proven World Health Organization (WHO) type II/III untreated nasopharyngeal carcinoma
- Non-metastatic nasopharyngeal carcinoma (stage I-IVA according to the 8th edition of the AJCC/UICC clinical staging system)
- Age over 18 years at diagnosis
- Eastern Cooperative Oncology Group (ECOG) performance score of 0-1
- Receiving recommended curative treatments including definitive radiotherapy with or without three cycles of induction chemotherapy (gemcitabine-cisplatin or paclitaxel-cisplatin regimen)
- Pre-treatment and post-first induction chemotherapy cycle plasma Epstein-Barr virus DNA detectable (> 0 copy/mL) with ongoing monitoring during induction chemotherapy
- Normal blood counts and organ function: hemoglobin > 90 g/L; neutrophils > 1.5 x 10^9/L; platelets > 100 x 10^9/L; total bilirubin ≤ 1.5 times upper limit of normal; ALT and AST ≤ 2.5 times upper limit of normal; alkaline phosphatase ≤ 2.5 times upper limit of normal; creatinine clearance ≥ 60 mL/min
- Female participants able to become pregnant agree to use reliable contraception from screening until 1 year after treatment
- Willing and able to provide informed consent and comply with study visits, treatments, laboratory tests, and study requirements
You will not qualify if you...
- Receiving surgery, targeted therapy, or immunotherapy during or before induction chemotherapy phase
- Having other previous or concurrent cancers except adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or thyroid papillary cancer
- Being pregnant or breastfeeding
- Previously treated with radical radiotherapy except for non-melanoma skin cancers outside intended treatment area
- Having uncontrolled heart disease, including heart failure NYHA class 2 or higher, unstable angina, recent myocardial infarction within 1 year, or arrhythmias requiring treatment or intervention
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hunan cancer Hospital
Changsha, Hunan, China
Actively Recruiting
Research Team
Y
Yaqian Han
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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