Development of a Novel Methodology Using BMVC Staining as... | NCT01301690

Studies
Development of a Novel Methodology Using BMVC Staining as an Assistance to Cancer Cytological Diagnosis

NCT01301690

Sponsor

Far Eastern Memorial Hospital

Status

Unknown status

Last Update Posted

Sep 19, 2011Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Neck Mass

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

Sep 2011

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 2010

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 21, 2011

First Submission Date that Met QC Criteria

Feb 22, 2011

First Posted Date

Feb 23, 2011Estimated

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

Sep 16, 2011

Last Update Posted Date

Sep 19, 2011Estimated

Description Module

Brief Summary

3,6-bis(1-methyl-4-vinylpyridinium) carbazole diiodide (BMVC) is an inorganic chemical compound (Figure1). The uptake of BMVC in cancer cells and normal cells are different. Recently, a simple handheld device (Figure1) based on the fluorescence analysis of stained cells was established to instantly differentiate cancer cells from normal cells. The investigators want to quantitatively measure the fluorescence expression of BMVC in normal and cancer cells and explore the usefulness of this staining in head and neck lumps.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
Neck masses		Neck mass received US and US-FNA

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients (age range from 18 to 90 years old) with neck lumps, receiving sonographic examination and FNA cytologic study.

Exclusion Criteria:

No cytology data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

We propose to collect consecutive patients (age range from 18 to 90 years old) with neck lumps, receiving sonographic examination and FNA cytologic study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Li-Jen Liao, MD	Contact	+886-0-8967-1592		deniro@mail2000.com.tw

Overall Officials

Name	Affiliation	Role
Li-Jen Liao, MD	Department of Otolaryngology Far Eastern Memorial Hospital, Taipei, Taiwan	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Otolaryngology Far Eastern Memorial Hospital	Recruiting	Taipei			Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19305919	Background	Liao LJ, Kang CC, Jan IS, Chen HC, Wang CL, Lou PJ, Chang TC. Improved diagnostic accuracy of malignant neck lumps by a simple BMVC staining assay. Analyst. 2009 Apr;134(4):708-11. doi: 10.1039/b814417f. Epub 2009 Jan 24.