NCT03290001

Brief Summary

This is a prospective, observational cohort study aimed to explore the influence of anxiety and depression to long term survival in nasopharyngeal carcinoma patients.

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 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

Study Start

First participant enrolled

August 20, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 21, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

5.1 years

First QC Date

September 3, 2017

Last Update Submit

November 4, 2017

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Progress-free survival

    Progress-free survival is calculated from the date of registration to the date of the first progress at any site.

    3 years

Secondary Outcomes (7)

  • Anxiety related measure

    Baseline, completion of radiation therapy (up to 12 weeks)

  • Distress related measure

    Baseline, completion of radiation therapy (up to 12 weeks)

  • Overall Survival(OS)

    3 years

  • Locoregional Relapse-Free Survival(LRFS)

    3 years

  • Distant Metastasis-Free Survival (DMFS)

    3 years

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

University hospital

You may qualify if:

  • Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
  • Age between 18-70
  • Male and no pregnant female
  • Patient have signed on the informed consent, and well understood the objective and procedure of this study

You may not qualify if:

  • The presence of uncontrolled life-threatening illness
  • Pregnancy or lactation
  • Patient with severe medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

HaiQiang Mai

CONTACT

8620-8734-3380maihq@sysucc.org.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of the Department of Nasopharyngeal Carcinoma

Study Record Dates

First Submitted

September 3, 2017

First Posted

September 21, 2017

Study Start

August 20, 2017

Primary Completion

September 20, 2022

Study Completion

September 20, 2022

Last Updated

November 7, 2017

Record last verified: 2017-11

Locations

CN(1)