NCT03003182

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 26, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

May 10, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

June 15, 2017

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

December 18, 2016

Last Update Submit

June 13, 2017

Conditions

Nasopharyngeal Cancer

Outcome Measures

Primary Outcomes (1)

  • overall survival

    3-years

Secondary Outcomes (1)

  • Number of participants with treatment-related acute adverse events as assessed by CTCAE v4.0

    30-days

Study Arms (2)

in clinical trials

out of clinical trials

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study includes patients with nasopharyngeal carcinoma in all stages.

You may qualify if:

  • 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;

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (1)

  • Yang SS, Wu YS, Pang YJ, Xiao SM, Zhang BY, Liu ZQ, Chen EN, Zhang X, OuYang PY, Xie FY. Development and validation of radiologic scores for guiding individualized induction chemotherapy in T3N1M0 nasopharyngeal carcinoma. Eur Radiol. 2022 Jun;32(6):3649-3660. doi: 10.1007/s00330-021-08460-1. Epub 2022 Jan 6.

    PMID: 34989842DERIVED

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Fang-Yun Xie, MD

CONTACT

+86-02087342618xiefy@sysucc.org.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

December 18, 2016

First Posted

December 26, 2016

Study Start

May 10, 2017

Primary Completion

May 1, 2019

Study Completion

May 1, 2021

Last Updated

June 15, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)