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| Name | Class |
|---|---|
| Xinqiao Hospital of Chongqing | OTHER |
| First Hospital of China Medical University | OTHER |
| Beijing Tiantan Hospital | OTHER |
| First Affiliated Hospital of Wenzhou Medical University |
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The purpose of this study is to observe whether dopamine agonists can be safely withdrawn after the tumor volume and prolactin level of invasive prolactinomas involving the cavernous sinus have been effectively controlled through pharmacological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.
For giant or large invasive prolactinomas involving the cavernous sinus, whether the drug can be safely withdrawn after the tumor volume and prolactin(PRL) level have been effectively controlled through pharmacological treatment still remains unknown.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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Withdrawal group | Withdrawal observation after reaching the withdrawal standard | ||
| Continue treatment group | Continue treatment obsevation after reaching the withdrawal standard |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on PRL level | Record the result of PRL on every 3 month follow-up visit | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 2 years |
| Change from baseline of visual acuity |
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Inclusion Criteria:
Exclusion Criteria:
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invasive prolactinomas involving the cavernous sinus
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhebao Wu, Medical PhD | Contact | 21-64370045 | 666091 | zhebaowu@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhebao Wu, Medical PhD | Ruijin Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | China | ||
| Peking Union Medical College Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16509147 | Background | 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. | |
| 17917811 | Background | 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. |
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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.
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| ID | Term |
|---|---|
| D015175 | Prolactinoma |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| OTHER |
| First Affiliated Hospital of Fujian Medical University | OTHER |
| Peking Union Medical College Hospital | OTHER |
| Huashan Hospital | OTHER |
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Whole blood; urine; tumor specimens (if possible)
Record the Visual acuity on every 3 month follow-up visit
| 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 | Up to 2 years |
| Recruiting |
| Beijing |
| Beijing Municipality |
| China |
| Xinqiao Hospital of Chongqing | Recruiting | Chongqing | Chongqing Municipality | China |
| First Affiliated Hospital of Fujian Medical University | Recruiting | Fuzhou | Fujian | China |
| The First Hospital of China Medical University | Recruiting | Shenyang | Liaoning | China |
| Ruijin Hosipital | Enrolling by invitation | Shanghai | Shanghai Municipality | 200025 | China |
| Huashan Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
| First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | China |
| D010911 |
| Pituitary Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |