Invasive Prolactinomas Involving the Cavernous SinusNCT02536261
Dopamine Agonists Withdrawal Study of Invasive Prolactinomas Involving the Cavernous Sinus
An observational study of Invasive Prolactinomas Involving the Cavernous Sinus, run by Zhebao Wu at 8 sites in China.
Trial 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The purpose of this study is to observe whether dopamine agonists can be safely withdrawn after the tumor volume and prolactin level of invasive prolactinomas involving the cavernous sinus have been effectively controlled through pharmacological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. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Invasive Prolactinomas Involving the Cavernous Sinus
- How many people
- 30 participants
- Where
- 8 sitesChina
- Study dates
- Jun 2016to Dec 2019
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: invasive prolactinomas involving the cavernous sinus
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
- Recruiting
Xinqiao Hospital of Chongqing
Chongqing, Chongqing Municipality
- Recruiting
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
- Enrolling by invitation
Ruijin Hosipital
Shanghai, Shanghai Municipality, 200025
- Recruiting
Huashan Hospital
Shanghai, Shanghai Municipality
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning
- Recruiting
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
About this study
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.
Read the 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.
- Keywords
- Prolactinoma, dopamine agonist, withdrawal, cavernous sinus
- Medical subject headings
- Prolactinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Withdrawal group | Withdrawal observation after reaching the withdrawal standard | |
| Continue treatment group | Continue treatment obsevation after reaching the withdrawal standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on PRL level
Record the result of PRL on every 3 month follow-up visit
Measured: Up to 2 years
Secondary outcomes (3)
Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI）
Record the tumor volume from enhanced pituitary MRI on every 3 month follow-up visits
Measured: Up to 2 years
Change from baseline of visual acuity
Record the Visual acuity on every 3 month follow-up visit
Measured: Up to 2 years
Change from baseline on 5 point visual field scale
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
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startJun 2016
- Primary completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Invasive Prolactinomas Involving the Cavernous SinusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Zhebao Wu
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor-investigator, Zhebao Wu, Ruijin Hospital
- Investigators
- Zhebao Wu, Medical PhD, Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536261
- Sponsor's protocol ID
- WSIP-1586
- Status last verified
- May 2017
- First submitted
- 15 Aug 2015
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 16509147Wu 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.
PubMed 17917811
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopamine Agonists Withdrawal Study of Invasive Prolactinomas Involving the Cavernous Sinus
- ClinicalTrials.gov ID
- NCT02536261
- Acronym / sponsor ID
- WSIP-1586
- Keywords
- Prolactinoma, dopamine agonist, withdrawal, cavernous sinus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhebao WuUniversity, hospital or other
- 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
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2019 (estimated)
- First posted
- 31 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Withdrawal group | – | –Withdrawal observation after reaching the withdrawal standard |
| Continue treatment group | – | –Continue treatment obsevation after reaching the withdrawal standard |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- invasive prolactinomas involving the cavernous sinus
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline on PRL level
Time frame: Up to 2 years
Record the result of PRL on every 3 month follow-up visit
3 secondary outcomes
Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI）
Time frame: Up to 2 years
Change from baseline of visual acuity
Time frame: Up to 2 years
Change from baseline on 5 point visual field scale
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Background: PubMed 16509147Wu 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.
- Background: PubMed 17917811Wu 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.
- Individual participant dataSharing planned: Undecided. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhebao Wu, Medical PhD study chair
Ruijin Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Prolactinomas Involving the Cavernous Sinus, run by Zhebao Wu at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhebao Wu, Medical PhD (21-64370045 ext. 666091, zhebaowu@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on PRL level (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02536261, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.