Prospective Study for Molecular Biomarkers and Spatial Transcriptomics of Stage IVa Nasopharyngeal Carcinoma

Not yet recruiting

• Conditions: Stage IVA Nasopharyngeal Carcinoma
• Interventions: Radiation: Intensity modulated radiation therapy (IMRT) combined with chemotherapy

• Registration Number: NCT05912582
• Lead Sponsor: Jiangsu Cancer Institute & Hospital

Brief 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.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-21
• Last Update Submitted: 2023-06-21
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22
• Study Start: 2023-06-25
• Primary Completion: 2025-06-25
• Study Completion: 2025-12-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observation Group	Intensity modulated radiation therapy (IMRT) combined with chemotherapy	-

Primary Outcome Measures

Name	Time	Method
major pathological response	3 months after radiation therapy

Secondary Outcome Measures

Name	Time	Method
Overall Survival	2 years after radiation therapy
Progression-free Survival	2 years after radiation therapy

Trial Locations

Locations (1)

Jiangsu Cancer Hospital; 🇨🇳 Nanjing, China