Mucin Glycosylating Enzymes in Head and Neck Cancers | NCT01976377

Studies
Mucin Glycosylating Enzymes in Head and Neck Cancers

NCT01976377

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Dec 15, 2016Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Glycosyltion Enzymes and Function Abnormalities

Interventions

Not provided

Countries

Taiwan

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

Dec 2016

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

Oct 2013

Primary Completion Date

Oct 2017Estimated

Completion Date

Oct 2017Estimated

First Submitted Date

Oct 22, 2013

First Submission Date that Met QC Criteria

Oct 29, 2013

First Posted Date

Nov 5, 2013Estimated

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

Dec 13, 2016

Last Update Posted Date

Dec 15, 2016Estimated

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

Head and neck squamous cell carcinoma(HNSCC) is the fourth common malignancy in Taiwan. It accounts for 5.8% of all cancers and causes 2,463 deaths per year. Aberrant glycosylation is the hallmark of most human cancers, including HNSCC, and affects many cellular properties. This study is aimed at exploring the role of mucin glycosylating enzymes in HNSCC.

Detailed Description

Glycosylation is the most common post-translational modification of proteins. Aberrant glycosylation is the hallmark of most human cancers and affect many cellular properties, including cell proliferation, apoptosis, differentiation, transformation, migration and immune response.

Though widely explored in various human cancers, the role of mucin glycosylating enzymes in HNSCC has not been elucidated. Our aims is to analyze the expression patterns of mucin glycosylating enzymes in HNSCC tissues. Furthermore, we will correlate the expression levels of mucin glycosylating enzymes with clinical characteristics of HNSCC patients.

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

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stage I, II, III, IV HNSCC		Stage I, II, III, IV HNSCC reveive treatment in NTUH

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure the expression of mucin glycosylating in head and neck cancer		1~5 years after patient received surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Head and neck cancer patients receiving operation in National Taiwan University Hospital

Exclusion Criteria:

Recurrence or non-operable patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Head and neck cancer patients receiving operation in National Taiwan University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pei-Jen Lou, M.D, Ph.D	Contact	886-972651527		pjlou@ntu.edu.tw
Mei-Chun Lin	Contact	886-978261268		b91401051@ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Pei-Jen Lou, M.D, Ph.D	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University	Recruiting	Taipei	Taiwan	100	Taiwan