Study on Therapy of Non-invasive Prolactinoma | NCT03353025

Studies
Study on Therapy of Non-invasive Prolactinoma

NCT03353025

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Status

Unknown status

Last Update Posted

Nov 24, 2017Actual

Enrollment

394Estimated

Phase

Not Applicable

Conditions

Prolactinoma

Interventions

transsphenoidal surgery treatment
dopamine agonist treatment

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

Nov 2017

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 1, 2016Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Feb 20, 2017

First Submission Date that Met QC Criteria

Nov 20, 2017

First Posted Date

Nov 24, 2017Actual

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

Nov 20, 2017

Last Update Posted Date

Nov 24, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hai-Jun Wang, director, First Affiliated Hospital, Sun Yat-Sen UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital, Sun Yat-Sen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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 study aim to investigate the endocrine remission rate of non-invasive prolactinoma between transsphenoidal surgery treatment and Dopamine agonist treatment.

Detailed Description

Non-invasive prolactinomas were treated by transsphenoidal surgery or Dopamine agonist until now. However，this two type therapies were controversial. The study aim to investigate the endocrine remission rate of non-invasive prolactinoma between transsphenoidal surgery treatment and Dopamine agonist treatment.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

394Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
transsphenoidal surgery treatment	Experimental	Transsphenoidal surgery treat non-invasive prolactinoma by experienced neurosurgeon	Procedure: transsphenoidal surgery treatment
dopamine agonist treatment	Experimental	Minimum effective dose of dopamine agonist, bromocriptine, treat non-invasive prolactinoma	Drug: dopamine agonist treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transsphenoidal surgery treatment	Procedure	transsphenoidal surgery treatment	transsphenoidal surgery treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Endocrine remission rate	After intervention, blood prolactin normalization rate	five-year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

non-invasive prolactionma

Exclusion Criteria:

invasive prolactioma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zongming Wang, Dr.	Contact	8613570903721		wzmyan@foxmail.com

Overall Officials

Name	Affiliation	Role
Haijun Wang, Dr.	First Affiliated Hospital, Sun Yat-Sen University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-sen 5010 program	Recruiting	Guangzhou			China

Condition Browse Module

MeSH Terms

ID	Term
D015175	Prolactinoma

Ancestor Terms

ID	Term
D000236	Adenoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided