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

Stage IVA Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05912582
• Other study ID #: Biomarkers-Stage IVa NPC
• Status: Not yet recruiting
• Start date: June 25, 2023
• Est. completion date: December 25, 2025

Study information

• Verified date: June 2023
• Source: Jiangsu Cancer Institute & Hospital
• Contact: Lirong Wu
• Phone: +86-13701588737
• Email: wulirong126[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 25, 2025
• Est. primary completion date: June 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Stage IVA Nasopharyngeal Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Jiangsu Cancer Hospital	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Cancer Institute & Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major pathological response		3 months after radiation therapy
Secondary	Progression-free Survival		2 years after radiation therapy
Secondary	Overall Survival		2 years after radiation therapy