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Dopamine Agonists Withdrawal Study of Invasive Prolactinomas Involving the Cavernous Sinus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02536261
Recruitment Status : Unknown
Verified May 2017 by Zhebao Wu, Ruijin Hospital.
Recruitment status was:  Recruiting
First Posted : August 31, 2015
Last Update Posted : May 16, 2017
Sponsor:
Collaborators:
Xinqiao Hospital of Chongqing
First Hospital of China Medical University
Beijing Tiantan Hospital
First Affiliated Hospital of Wenzhou Medical University
First Affiliated Hospital of Fujian Medical University
Peking Union Medical College Hospital
Huashan Hospital
Information provided by (Responsible Party):
Zhebao Wu, Ruijin Hospital

Brief Summary:
The purpose of this study is to observe whether dopamine agonists can be safely withdrawn after the tumor volume and prolactin level of invasive prolactinomas involving the cavernous sinus have been effectively controlled through pharmacological treatment.

Condition or disease
Invasive Prolactinomas Involving the Cavernous Sinus

Detailed Description:
For giant or large invasive prolactinomas involving the cavernous sinus, whether the drug can be safely withdrawn after the tumor volume and prolactin(PRL) level have been effectively controlled through pharmacological treatment still remains unknown. The study objects are patients with invasive prolactinomas involving the cavernous sinus, which were invaded the cavernous sinus to an extent corresponding to Grade III or IV, according to the classification scheme of Knosp and colleagues, who had undergone pharmacological treatment including bromocriptine or cabergoline. Observation will be started after drug withdrawal criteria are reached (PRL remains normal level for no less than two years; tumor volume has shrank more than 50%, and the distance is more than 5mm between tumor and optical nerve),the patients are randomized to withdrawal group or continue treatment group.Observational items include changes of PRL level, tumor volume as well as vision acuity and visual fields. If elevated PRL or tumor relapse is observed, pharmacological treatment will be restarted.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Dopamine Agonists Withdrawal Study of Invasive Prolactinomas Involving the Cavernous Sinus
Actual Study Start Date : June 2016
Estimated Primary Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dopamine

Group/Cohort
Withdrawal group
Withdrawal observation after reaching the withdrawal standard
Continue treatment group
Continue treatment obsevation after reaching the withdrawal standard



Primary Outcome Measures :
  1. Change from baseline on PRL level [ Time Frame: Up to 2 years ]
    Record the result of PRL on every 3 month follow-up visit


Secondary Outcome Measures :
  1. Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging(MRI) [ Time Frame: Up to 2 years ]
    Record the tumor volume from enhanced pituitary MRI on every 3 month follow-up visits

  2. Change from baseline of visual acuity [ Time Frame: Up to 2 years ]
    Record the Visual acuity on every 3 month follow-up visit

  3. Change from baseline on 5 point visual field scale [ Time Frame: Up to 2 years ]
    Record the Visual field scale on every 3 month follow-up visit, 0 = normal, no vision loss; 1 = one quadrant vision loss; 2 = two quadrants of vision loss; 3 = three quadrants of vision loss; 4 = four quadrants of vision loss but retain a central tubular vision; 5 = blind


Biospecimen Retention:   Samples With DNA
Whole blood; urine; tumor specimens (if possible)


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
invasive prolactinomas involving the cavernous sinus
Criteria

Inclusion Criteria:

  1. Aged between 15 and 70 years old, either sex;
  2. Karnofsky performance status ≥ 70;
  3. Patients who were suffered Invasive prolactinomas involving the cavernous sinus , referring to ①Serum prolactin level>200ng/ml, or >4000mIU/L;②enhanced Magnetic Resonance images confirm tumor invasion into cavernous sinus, i.e. Knosp grade Ⅲ or Ⅳ, and were treated by dopamine agonists treatment;
  4. PRL remains normal level for no less than two years;
  5. Tumor volume has shrank more than 50%, and the distance is more than 5mm between tumor and optical nerve;
  6. The patient has signed the informed consent.

Exclusion Criteria:

  1. Patients concomitantly taking the psychotropic drugs or other drugs causing elevated PRL ;
  2. Patients with parkinson disease and is taking dopaminergic agents;
  3. Patients with prolactinoma who received Gamma knife treatment;
  4. Patients who use any dopamine receptor agonists other than bromocriptine and cabergoline;
  5. Patients taking the other prolactinomas simultaneously;
  6. pregnant or lactating women, or women preparing pregnant;
  7. Patients with poor compliance, who cannot implement the program strictly.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536261


Contacts
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Contact: Zhebao Wu, Medical PhD 21-64370045 ext 666091 zhebaowu@aliyun.com

Locations
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China, Beijing
Beijing Tiantan Hospital Recruiting
Beijing, Beijing, China
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China
China, Chongqing
Xinqiao Hospital of Chongqing Recruiting
Chongqing, Chongqing, China
China, Fujian
First Affiliated Hospital of Fujian Medical University Recruiting
Fuzhou, Fujian, China
China, Liaoning
The First Hospital of China Medical University Recruiting
Shenyang, Liaoning, China
China, Shanghai
Ruijin Hosipital Enrolling by invitation
Shanghai, Shanghai, China, 200025
Huashan Hospital Recruiting
Shanghai, Shanghai, China
China, Zhejiang
First Affiliated Hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China
Sponsors and Collaborators
Zhebao Wu
Xinqiao Hospital of Chongqing
First Hospital of China Medical University
Beijing Tiantan Hospital
First Affiliated Hospital of Wenzhou Medical University
First Affiliated Hospital of Fujian Medical University
Peking Union Medical College Hospital
Huashan Hospital
Investigators
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Study Chair: Zhebao Wu, Medical PhD Ruijin Hospital
Additional Information:

Publications:
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Responsible Party: Zhebao Wu, Chief Physician, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT02536261    
Other Study ID Numbers: WSIP-1586
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The individual patient Data would not be shared to the third facility, but the sponsor hasn't decided whether to share the individual patient date to the other related studies hold by himself in the future.
Keywords provided by Zhebao Wu, Ruijin Hospital:
Prolactinoma
dopamine agonist
withdrawal
cavernous sinus
Additional relevant MeSH terms:
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Prolactinoma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases