The Predictive Factors of Vision Recovery in Patients Wit... | NCT01377701

Studies
The Predictive Factors of Vision Recovery in Patients With Pituitary Tumor

NCT01377701

Sponsor

Huashan Hospital

Status

Unknown status

Last Update Posted

Jun 21, 2011Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Pituitary Adenomas

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

Jun 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

Jun 2011

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Jun 20, 2011

First Submission Date that Met QC Criteria

Jun 20, 2011

First Posted Date

Jun 21, 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

Jun 20, 2011

Last Update Posted Date

Jun 21, 2011Estimated

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

Pituitary adenomas can cause compression of optic nerves and chiasm, which will lead to damage of vision. This study aims to evaluate the predictive factors for recovery of vision in patients with pituitary adenomas following trans-sphenoidal surgery.

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

150Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>18 years old
patients with pituitary adenomas, loss of visual field
patients receive trans-sphenoidal surgery

Exclusion Criteria:

visual damage caused by other diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with pituitary adenomas at Huashan Hospital will be screened. Patients with loss of visual field and receive trans-sphenoidal surgery will be included.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yao Zhao, M.D.	Contact	86-13916872553		zhaoyaohs@vip.sina.com

Overall Officials

Name	Affiliation	Role
Yao Zhao, M.D.	Huashan Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Huashan Hospital	Recruiting	Shanghai		200040	China

Condition Browse Module

MeSH Terms

ID	Term
D010911	Pituitary Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D007029	Hypothalamic Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided