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

Sponsor
Jiangsu Cancer Institute & Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05912582
Collaborator
(none)
60
Enrollment
1
Location
30
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: Intensity modulated radiation therapy (IMRT) combined with chemotherapy

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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Study for Molecular Biomarkers and Spatial Transcriptomics of Stage IVa Nasopharyngeal Carcinoma
Anticipated Study Start Date :
Jun 25, 2023
Anticipated Primary Completion Date :
Jun 25, 2025
Anticipated Study Completion Date :
Dec 25, 2025

Arms and Interventions

Arm Intervention/Treatment
Observation Group

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. major pathological response [3 months after radiation therapy]

    Secondary Outcome Measures

    1. Progression-free Survival [2 years after radiation therapy]

    2. Overall Survival [2 years after radiation therapy]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jiangsu Cancer Hospital Nanjing China

    Sponsors and Collaborators

    • Jiangsu Cancer Institute & Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lirong Wu, Associate Professor, Jiangsu Cancer Institute & Hospital
    ClinicalTrials.gov Identifier:
    NCT05912582
    Other Study ID Numbers:
    • Biomarkers-Stage IVa NPC
    First Posted:
    Jun 22, 2023
    Last Update Posted:
    Jun 22, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Lirong Wu, Associate Professor, Jiangsu Cancer Institute & Hospital
    Nasopharyngeal Carcinoma
    Biomarker
    Spatial Transcriptomics
    Additional relevant MeSH terms:
    Carcinoma
    Nasopharyngeal Carcinoma

    Study Results

    No Results Posted as of Jun 22, 2023