Function and Modulation of Fibulin-1 Assembly in Nucleus... | NCT01808495

Studies
Function and Modulation of Fibulin-1 Assembly in Nucleus of Corneal Fibroblasts

NCT01808495

Sponsor

Far Eastern Memorial Hospital

Status

Unknown status

Last Update Posted

Aug 13, 2015Estimated

Enrollment

5Estimated

Phase

Not provided

Conditions

Function of Mitomycin C in Cornea

Interventions

Mitomycin C

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

ID	Type	Description	Link
NSC101-2320-B-418-002	Other Grant/Funding Number	NSC101-2320-B-418-002

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Jul 2013Actual

Completion Date

Aug 2015Estimated

First Submitted Date

Sep 13, 2012

First Submission Date that Met QC Criteria

Mar 8, 2013

First Posted Date

Mar 11, 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

Aug 10, 2015

Last Update Posted Date

Aug 13, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tsan-Chi Chen, Department of Ophthalmology, Far Eastern Memorial HospitalPrincipal Investigator

Lead Sponsor

Far Eastern Memorial HospitalOTHER

Collaborators

Not provided

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 study is to investigate the role of nuclear Fibulin-1 (FBLN1) in Human Corneal Fibroblasts under treatment of mitomycin C (MMC).

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

5Estimated

Name	Type	Description	Arm Group Labels	Other Names
Mitomycin C	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Modification of nuclear Fibulin-1 accumulation in suppressing gene expression		3 days post mitomycin C treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The frozen storage cells in liquid nitrogen were amplified from the residual corneal rim of the donors with more than 20 years old following penetrating keratoplasty.

Exclusion Criteria:

The donors were younger than 20 years old.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The original cell sources were collected from the donors with more than 20 years old following penetrating keratoplasty. After successfully amplified from the residual corneal rim following penetrating keratoplasty in the previous projects, human corneal fibroblasts (HCFs) were reserved in liquid nitrogen tank and were thawed for this study under in vitro cultivation and application.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tsan-Chi Chen, PhD	Far Eastern Memorial Hospital	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016685	Mitomycin

Ancestor Terms

ID	Term
D008937	Mitomycins
D045563	Indolequinones
D011809	Quinones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided