A Study of Nasopharyngeal Carcinoma From Guangdong

June 13, 2017 updated by: Fang-Yun Xie, Sun Yat-sen University

A Prospective Cohort Study of Nasopharyngeal Carcinoma to Establish Prognostic Models, to Discover Toxicity Associated Predictors and to Validate Randomized Trials in Clinical Practice

This prospective cohort study aims to establish prognostic models, to discover toxicity associated predictors and to validate randomized trials in clinical practice.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study includes patients with nasopharyngeal carcinoma in all stages.

Description

Inclusion Criteria:

  • histological confirmed nasopharyngeal carcinoma;
  • scanned by magnetic resonance imaging from calvaria vertex to clavicles before treatment;
  • pretreatment Epstein-Barr virus deoxyribonucleic acid copy number is available;
  • irradiated with intensity-modulated radiotherapy;

Exclusion Criteria:

  • finishing anticancer therapy in two or more hospitals;
  • pregnancy or lactation;
  • diagnosed with other sort of cancer before or during the treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
in clinical trials
out of clinical trials

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 3-years
3-years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-related acute adverse events as assessed by CTCAE v4.0
Time Frame: 30-days
30-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2017

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

December 18, 2016

First Submitted That Met QC Criteria

December 23, 2016

First Posted (Estimate)

December 26, 2016

Study Record Updates

Last Update Posted (Actual)

June 15, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-FXY-098-Dept. of RT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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