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Trial Title:
Prospective Study for Molecular Biomarkers and Spatial Transcriptomics of Stage IVa Nasopharyngeal Carcinoma
NCT ID:
NCT05912582
Condition:
Stage IVA Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Conditions: Keywords:
Nasopharyngeal Carcinoma
Biomarker
Spatial Transcriptomics
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Radiation
Intervention name:
Intensity modulated radiation therapy (IMRT) combined with chemotherapy
Description:
Intensity modulated radiation therapy (IMRT) combined with chemotherapy
Arm group label:
Observation Group
Other name:
IMRT
Summary:
This clinical research aims to explore potential biomarkers and validate molecular
signatures' predictive and prognostic value in stage IVa nasopharyngeal carcinoma.
Detailed description:
Primary endpoint: Evaluation of the major pathological response of stage IVa
nasopharyngeal carcinoma patients.
Secondary endpoint: Evaluation of failure-free survival and overall survival of stage IVa
nasopharyngeal carcinoma patients.
Outline: This is a prospective observational study. Patients of stage IVa 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 stage IVa nasopharyngeal carcinoma. This will lead to
the definition of risk groups and stratification of patients and will help in precision
medicine of stage IVa nasopharyngeal carcinoma.
Criteria for eligibility:
Study pop:
Patients with newly histologically confirmed stage IVa nasopharyngeal carcinoma
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Patients with newly histologically confirmed stage IVa nasopharyngeal carcinoma
2. No evidence of distant metastasis (M0)
3. Written informed consent
Exclusion Criteria:
Treatment with palliative intent
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jiangsu Cancer Hospital
Address:
City:
Nanjing
Country:
China
Contact:
Last name:
Lirong Wu
Email:
wulirong126@126.com
Start date:
June 25, 2023
Completion date:
December 25, 2025
Lead sponsor:
Agency:
Jiangsu Cancer Institute & Hospital
Agency class:
Other
Source:
Jiangsu Cancer Institute & Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05912582
