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Prospective Study for Molecular Biomarkers and Spatial Transcriptomics of Nasopharyngeal Carcinoma

J

Jiangsu Cancer Hospital

Status

Not yet enrolling

Conditions

Nasopharyngeal Carcinoma

Treatments

Radiation: Intensity modulated radiation therapy (IMRT) combined with chemotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT05912582
Biomarkers- NPC

Details and patient eligibility

About

This clinical research aims to explore potential biomarkers and validate molecular signatures' predictive and prognostic value in nasopharyngeal carcinoma.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients with newly histologically confirmed nasopharyngeal carcinoma
  2. No evidence of distant metastasis (M0)
  3. Written informed consent

Exclusion criteria

Treatment with palliative intent

Trial design

60 participants in 1 patient group

Observation Group
Treatment:
Radiation: Intensity modulated radiation therapy (IMRT) combined with chemotherapy

Trial contacts and locations

1

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Central trial contact

Lirong Wu

Data sourced from clinicaltrials.gov

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