Prospective Study for Prognostic Biomarkers of Nasopharyn... | NCT03025854

Studies
Prospective Study for Prognostic Biomarkers of Nasopharyngeal Carcinoma

NCT03025854

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Oct 12, 2020Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Nasopharyngeal Carcinoma

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

Dec 2022Estimated

Completion Date

Jan 2023Estimated

First Submitted Date

Jan 18, 2017

First Submission Date that Met QC Criteria

Jan 19, 2017

First Posted Date

Jan 20, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2020

Last Update Posted Date

Oct 12, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jun Ma, MD, Prof, Sun Yat-sen UniversityPrincipal Investigator

Lead Sponsor

Sun Yat-sen UniversityOTHER

Collaborators

Name	Class
Guilin Medical University, China	OTHER
First People's Hospital of Foshan	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

600Estimated

Measure	Description	Time Frame
Failure-free Survival		3 years

Measure	Description	Time Frame
Overall Survival		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with newly histologically confirmed nasopharyngeal carcinoma
No evidence of distant metastasis (M0)
Written informed consent

Exclusion Criteria:

Treatment with palliative intent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with newly histologically confirmed nasopharyngeal carcinoma and no evidence of distant metastasis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jun Ma, M.D.	Contact	+86-20-87343469		majun2@mail.sysu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-sen University Cancer Center	Recruiting	Guangzhou	Guangdong	510060	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000077274	Nasopharyngeal Carcinoma

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided