NCT02536261

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The purpose of this study is to observe whether dopamine agonists can be safely withdrawn after the tumor volume and prolactin level of invasive prolactinomas involving the cavernous sinus have been effectively controlled through pharmacological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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 31, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

3.5 years

First QC Date

August 15, 2015

Last Update Submit

May 15, 2017

Conditions

Invasive Prolactinomas Involving the Cavernous Sinus

Keywords

Prolactinomadopamine agonistwithdrawalcavernous sinus

Outcome Measures

Primary Outcomes (1)

  • Change from baseline on PRL level

    Record the result of PRL on every 3 month follow-up visit

    Up to 2 years

Secondary Outcomes (3)

  • Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI）

    Up to 2 years

  • Change from baseline of visual acuity

    Up to 2 years

  • Change from baseline on 5 point visual field scale

    Up to 2 years

Study Arms (2)

Withdrawal group

Withdrawal observation after reaching the withdrawal standard

Continue treatment group

Continue treatment obsevation after reaching the withdrawal standard

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

invasive prolactinomas involving the cavernous sinus

You may qualify if:

  • Aged between 15 and 70 years old, either sex;
  • Karnofsky performance status ≥ 70;
  • 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;
  • 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 patient has signed the informed consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Xinqiao Hospital of Chongqing

Chongqing, Chongqing Municipality, China

RECRUITING

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

Ruijin Hosipital

Shanghai, Shanghai Municipality, 200025, China

ENROLLING BY INVITATION

Huashan Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

Related Publications (2)

  • Wu ZB, Yu CJ, Su ZP, Zhuge QC, Wu JS, Zheng WM. Bromocriptine treatment of invasive giant prolactinomas involving the cavernous sinus: results of a long-term follow up. J Neurosurg. 2006 Jan;104(1):54-61. doi: 10.3171/jns.2006.104.1.54.

    PMID: 16509147BACKGROUND

  • Wu ZB, Su ZP, Wu JS, Zheng WM, Zhuge QC, Zhong M. Five years follow-up of invasive prolactinomas with special reference to the control of cavernous sinus invasion. Pituitary. 2008;11(1):63-70. doi: 10.1007/s11102-007-0072-4.

    PMID: 17917811BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood; urine; tumor specimens (if possible)

MeSH Terms

Conditions

Prolactinoma

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPituitary NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SitePituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Zhebao Wu, Medical PhD

    Ruijin Hospital

    STUDY CHAIR

Central Study Contacts

Zhebao Wu, Medical PhD

CONTACT

21-64370045zhebaowu@aliyun.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

August 15, 2015

First Posted

August 31, 2015

Study Start

June 1, 2016

Primary Completion

December 1, 2019

Last Updated

May 16, 2017

Record last verified: 2017-05

Locations

CN(8)