Study of Biomarker From Blood and Tissue of Head and Neck... | NCT01171235

Studies
Study of Biomarker From Blood and Tissue of Head and Neck Carcinoma

NCT01171235

Sponsor

Southern Medical University, China

Status

Unknown status

Last Update Posted

Jul 28, 2010Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Laryngeal Neoplasms
Pharyngeal Neoplasms

Interventions

Not provided

Countries

Not provided

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

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Dec 2011Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Jul 27, 2010

First Submission Date that Met QC Criteria

Jul 27, 2010

First Posted Date

Jul 28, 2010Estimated

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

Jul 27, 2010

Last Update Posted Date

Jul 28, 2010Estimated

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 aim of the study is to find for one or more serum or tissue markers of molecular biology in head and neck cancer patients used for early diagnosis, predicting prognosis and being sensitive to chemotherapy and radiotherapy

Detailed Description

Head and neck malignant tumors, especially nasopharyngeal carcinoma in southern China with the high incidence, its incidence, treatment, prognosis or tumor markers in serum has been a hot research with little progress.In our study, we collect NPC-based collection including the blood samples of laryngeal, hypopharyngeal cancer, separating serum and white blood cells stored in -80 degrees，while tissues are frozen in liquid nitrogen and embedded in paraffin。 Patient treatment and prognosis are combined in order to find for markers of molecular biology used for early diagnosis, predicting prognosis and being sensitive to chemotherapy and radiotherapy.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all of nasopharyngeal carcinoma
hypopharyngeal carcinoma or laryngeal carcinoma visited at ENT department of NanFang hospital

Exclusion Criteria:

all of above patients whose anticipated survival duration were less than 6 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

all of nasopharyngeal carcinoma, hypopharyngeal carcinoma or laryngeal carcinoma visited at ENT department of NanFang hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ping Xiang Li, doctor	E.N.T department of NanFang hospital	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24481647	Derived	Yu BL, Peng XH, Zhao FP, Liu X, Lu J, Wang L, Li G, Chen HH, Li XP. MicroRNA-378 functions as an onco-miR in nasopharyngeal carcinoma by repressing TOB2 expression. Int J Oncol. 2014 Apr;44(4):1215-22. doi: 10.3892/ijo.2014.2283. Epub 2014 Jan 28.

ID	Term
D010039	Otorhinolaryngologic Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D007822	Laryngeal Neoplasms
D010610	Pharyngeal Neoplasms