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NCT03025854 Clinical Trial

Prospective Study for Prognostic Biomarkers of Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:
Prospective Study for Prognostic Biomarkers of Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03025854
Other study ID # 2016-FXY-058
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2017
Est. completion date January 2023

Study information
Verified date October 2020
Source Sun Yat-sen University
Contact Jun Ma, M.D.
Phone +86-20-87343469
Email majun2@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this clinical research project is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in nasopharyngeal carcinoma.

Description:

Objectives:

Primary: Evaluation of failure-free survival after three years of patients of nasopharyngeal carcinoma.

Secondary: Evaluation of overall survival after three years of patients of nasopharyngeal carcinoma.

Outline: This is a multicenter observational study. Tumor tissue specimens are obtained from the Sun Yat-sen University Cancer Center and Affiliated Hospital of Guilin Medical University. The samples are analyzed for biomarkers. The biomarkers are correlated with clinical outcomes (failure-free survival, overall survival, tumor response to treatment, distant metastasis, recurrence and death).

The aim of the analysis is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in nasopharyngeal carcinoma. This will lead to the definition of risk groups and stratification of patients and will help to precision medicine of nasopharyngeal carcinoma.

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date January 2023
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with newly histologically confirmed nasopharyngeal carcinoma

- No evidence of distant metastasis (M0)

- Written informed consent

Exclusion Criteria:

- Treatment with palliative intent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Sun Yat-sen University Cancer Center Guangzhou Guangdong

Sponsors (3)
Lead Sponsor Collaborator
Sun Yat-sen University First People's Hospital of Foshan, Guilin Medical University, China

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Failure-free Survival 3 years
Secondary Overall Survival 3 years
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