- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03353025
Study on Therapy of Non-invasive Prolactinoma (TNAPA)
November 20, 2017 updated by: Hai-Jun Wang, First Affiliated Hospital, Sun Yat-Sen University
Prospective Randomized Clinical Study on Transsphenoidal or Dopamine Drugs Therapy Treat Non-invasive Prolactinoma
the study aim to investigate the endocrine remission rate of non-invasive prolactinoma between transsphenoidal surgery treatment and Dopamine agonist treatment.
Study Overview
Status
Recruiting
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment (Anticipated)
394
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zongming Wang, Dr.
- Phone Number: 8613570903721
- Email: wzmyan@foxmail.com
Study Locations
-
-
-
Guangzhou, China
- Recruiting
- Sun Yat-sen 5010 program
-
Contact:
- Haijun Wang, doctor
- Phone Number: 13570903721
- Email: wanghaij@mail.sysu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
non-invasive prolactionma
Exclusion Criteria:
invasive prolactioma
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: transsphenoidal surgery treatment
Transsphenoidal surgery treat non-invasive prolactinoma by experienced neurosurgeon
|
transsphenoidal surgery treatment
Other Names:
|
EXPERIMENTAL: dopamine agonist treatment
Minimum effective dose of dopamine agonist, bromocriptine, treat non-invasive prolactinoma
|
Minimum effective dose of dopamine agonist,bromocriptine,treat prolactinona
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endocrine remission rate
Time Frame: five-year
|
After intervention, blood prolactin normalization rate
|
five-year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Haijun Wang, Dr., First Affiliated Hospital, Sun Yat-Sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2016
Primary Completion (ANTICIPATED)
December 31, 2025
Study Completion (ANTICIPATED)
December 31, 2025
Study Registration Dates
First Submitted
February 20, 2017
First Submitted That Met QC Criteria
November 20, 2017
First Posted (ACTUAL)
November 24, 2017
Study Record Updates
Last Update Posted (ACTUAL)
November 24, 2017
Last Update Submitted That Met QC Criteria
November 20, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Hypothalamic Diseases
- Pituitary Diseases
- Adenoma
- Pituitary Neoplasms
- Prolactinoma
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Cardiotonic Agents
- Dopamine Agents
- Sympathomimetics
- Dopamine
- Dopamine Agonists
Other Study ID Numbers
- 2016008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prolactinoma
-
Ohio State UniversityTerminatedPituitary Tumor | Prolactinoma | Prolactin-Producing Pituitary Tumor | Prolactinoma Macroadenoma | Prolactinoma MicroadenomaUnited States
-
Zhebao WuPeking Union Medical College Hospital; Beijing Tiantan Hospital; Chinese PLA... and other collaboratorsUnknownProlactinoma
-
Postgraduate Institute of Medical Education and...Unknown
-
Federal University of São PauloCompletedHypogonadotropic Hypogonadism | ProlactinomaBrazil
-
Columbia UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedProlactinoma | HyperprolactinemiaUnited States
-
Hacettepe UniversityHacettepe University, Faculty of MedicineCompleted
-
Zhebao WuPeking Union Medical College Hospital; Beijing Tiantan Hospital; Huashan Hospital and other collaboratorsUnknownInvasive Prolactinomas Involving the Cavernous SinusChina
-
Zhebao WuPeking Union Medical College Hospital; Beijing Tiantan Hospital; Chinese PLA... and other collaboratorsUnknownResistance, Disease | ProlactinomaChina
-
Federico II UniversityCompletedProlactinomasItaly
-
Memorial Sloan Kettering Cancer CenterEvergreen Theragnostics; Recordati Pharmaceutical companyRecruitingProlactin-Producing Pituitary TumorUnited States
Clinical Trials on transsphenoidal surgery treatment
-
St. Joseph's Hospital and Medical Center, PhoenixWashington University School of Medicine; Northwestern University; Ohio State... and other collaboratorsCompleted
-
Zhebao WuThe First Affiliated Hospital of Nanchang University; Shanghai Zhongshan Hospital and other collaboratorsUnknownQuality of Life | Pituitary Tumor | Endoscopic Surgery | Function of NoseChina
-
Shanghai Jiao Tong University School of MedicineFirst Affiliated Hospital, Sun Yat-Sen UniversityUnknown
-
Universitätsklinikum Hamburg-EppendorfBrigham and Women's HospitalRecruitingPituitary Adenoma | Pituitary Diseases | Pituitary TumorGermany
-
NYU Langone HealthCompleted
-
Fondation Ophtalmologique Adolphe de RothschildCompletedPituitary Tumor | Optic Chiasm Disorder
-
National Institute of Diabetes and Digestive and...CompletedAcromegaly | Pituitary NeoplasmUnited States
-
University of AarhusAarhus University HospitalCompletedInsulin Resistance | Acromegaly | Excessive Growth Hormone SecretionDenmark
-
Changhai HospitalNot yet recruitingBreast Neoplasms | Metastatic Breast Cancer | Treatment | Survival
-
Peking University Third HospitalNot yet recruitingAcute Myocardial Infarction