Prospective Study for Molecular Biomarkers and Spatial Transcriptomics of Nasopharyngeal Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intensity modulated radiation therapy (IMRT) combined with chemotherapy.
- Who it may be relevant to
- Registry conditions: Nasopharyngeal Carcinoma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This clinical research aims to explore potential biomarkers and validate molecular signatures' predictive and prognostic value in nasopharyngeal carcinoma.
Detailed description
Primary endpoint: Evaluation of the major pathological response of nasopharyngeal carcinoma patients.
Secondary endpoint: Evaluation of failure-free survival and overall survival of nasopharyngeal carcinoma patients.
Outline: This is a prospective observational study. Patients of nasopharyngeal carcinoma undergo inductive chemotherapy and concurrent chemoradiotherapy. Whole blood is obtained from patients when recruited, completing 10, 20, 32 fractions of radiation therapy, 3 months after radiation therapy and disease progression. Tumor tissue specimens are obtained from patients when recruited and disease progression. The samples are analyzed for biomarkers and spatial transcriptomics. The biomarkers and spatial transcriptomics are correlated with clinical outcomes (major pathological response, progression-free survival, overall survival, tumor response to treatment, distant metastasis, recurrence and death).
The analysis aims to explore potential biomarkers and validate molecular signatures' predictive and prognostic value in nasopharyngeal carcinoma. This will lead to the definition of risk groups and stratification of patients and will help in precision medicine of nasopharyngeal carcinoma.
Interventions
- Radiation Intensity modulated radiation therapy (IMRT) combined with chemotherapy
Intensity modulated radiation therapy (IMRT) combined with chemotherapy
Primary outcome measures
- major pathological response [Time frame: 3 months after radiation therapy]
Secondary outcome measures (2)
- Progression-free Survival [Time frame: 2 years after radiation therapy]
- Overall Survival [Time frame: 2 years after radiation therapy]
Eligibility criteria
Inclusion criteria
- Patients with newly histologically confirmed nasopharyngeal carcinoma
- No evidence of distant metastasis (M0)
- Written informed consent
Exclusion criteria
Treatment with palliative intent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Jiangsu Cancer Hospital — Nanjing
Identifiers
NCT: NCT05912582 · Biomarkers- NPC