Prospective Study for Molecular Biomarkers and Spatial Transcriptomics of Nasopharyngeal Carcinoma

NCT ID: NCT05912582

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-25

Study Completion Date

2028-12-25

Brief Summary

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

Detailed Description

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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.

Conditions

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Nasopharyngeal Carcinoma

Keywords

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Nasopharyngeal Carcinoma Biomarker Spatial Transcriptomics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observation Group

Intensity modulated radiation therapy (IMRT) combined with chemotherapy

Intervention Type RADIATION

Intensity modulated radiation therapy (IMRT) combined with chemotherapy

Interventions

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Intensity modulated radiation therapy (IMRT) combined with chemotherapy

Intensity modulated radiation therapy (IMRT) combined with chemotherapy

Intervention Type RADIATION

Other Intervention Names

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IMRT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu Cancer Institute & Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lirong Wu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jiangsu Cancer Hospital

Nanjing, , China

Site Status

Countries

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China

Central Contacts

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Lirong Wu

Role: CONTACT

Phone: +86-13701588737

Email: [email protected]

Facility Contacts

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Lirong Wu

Role: primary

Other Identifiers

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Biomarkers- NPC

Identifier Type: -

Identifier Source: org_study_id