Characterization of Receptors in Non-functioning Pituitary Macroadenomas
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Characterization of receptors present in non-functioning pituitary macroadenomas by Reverse Transcriptase- Polymerase Chain Reaction (RT-PCR) would assist with targeted medical therapy based on the information obtained by immunohistochemistry and RT-PCR.
| Condition | Intervention | Phase |
|---|---|---|
|
Pituitary Tumor |
Other: To perform RT-PCR on the tissue obtained during surgery |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Characterization of Receptors Present in Non-functioning Pituitary Macroadenomas by Reverse Transcriptase- Polymerase Chain Reaction (RT-PCR) |
- To determine the expression of hormonal receptors in clinically non-functioning pituitary macroadenomas by RT - PCR and immunohistochemistry. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To correlate the clinical, hormonal and radiological characteristics of the patients with pituitary tumors with the hormonal receptors status. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
A small piece of the pituitary macradenoma removed at surgery will be frozen to perform RT-PCR
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Non-functioning pituitary macroadenoma
The performance of surgery is the standard of care in the management of non-functioning pituitary macroadenomas. The tissue obtained during surgery is routinely sent for histopathological examination. A piece of the tissue will undergo receptor characterisation via RT-PCR.
|
Other: To perform RT-PCR on the tissue obtained during surgery
The performance of surgery is the standard of care in the management of non-functioning pituitary macroadenomas. The tissue obtained during surgery is routinely sent for histopathological examination. A piece of the tissue will undergo receptor characterisation via RT-PCR.
Other Name: Reverse Transcriptase polymerase chain reaction
|
Detailed Description:
The pituitary gland in the brain is the master hormonal gland and is surrounded by important nerves and blood vessels. The pituitary gland can develop various types of tumors, some which do not produce any hormones and are called non-functioning pituitary adenomas. These non-functioning tumors can grow and can cause compression of these important structures. The usual treatment of large non-functioning pituitary macroadenoma is surgery. As it is surrounded by neuro-vascular bundles, this makes complete removal of the tumor sometimes impossible and even dangerous. A large number of subjects will still have some residual tumor post-surgery. The risks of residual tumor are further growth with compression and compromise of the function of surrounding vital organs especially vision.
If there is further growth of the tumor the options at present are repeat surgery or radiotherapy. Repeat surgery involves all the risks associated with brain surgery and sometimes may not be possible if very close to vital organs, while radiotherapy will over a period of time lead to complete or partial deficiency of pituitary hormone function and has been associated with long term cognitive deficits. In addition radiotherapy has a lag time of 12-24 months prior to onset of action.
However, pituitary tumors that do not actively secrete hormones may still harbour receptors to various hormones. The blockage of these receptors by various medications may enable us to stop the tumor from growing or recurring after surgery. This may open up a novel means of treatment of these non functioning tumors. So far there is very little information in the literature about the type of receptors present in these tumors.
Our study proposes to obtain a piece of the tissue removed during surgery and perform receptor characterization to help improve our knowledge in that area. Also correlating the receptor status with the clinical, hormonal and radiological profile of the patients may help to develop improved treatment strategies in the future and help us to predict the possibility of tumor regrowth.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
All subjects who are diagnosed with a non-functioning pituitary macroadenoma who are scheduled for surgery.
Inclusion Criteria:
- Adults, both males and females age 18 years old or more
- Pituitary tumor more than 10 mm in diameter diagnosed by MRI
- No clinical or laboratory evidence of pituitary hormone oversecretion (non-functioning pituitary macroadenoma)
Exclusion Criteria:
- Subjects with pituitary tumors less than 10 mm in diameter
- Subjects with clinical or laboratory evidence of hormone oversecretion
- Presence of dementia
Contacts and Locations| Contact: Ambika Babu, MD | 312 864 0543 | Ambika_Babu@rush.edu |
| Contact: Leon A Fogelfeld, MD | 312 864 0540 | lfogelfe@cchil.org |
| United States, Illinois | |
| John H Stroger Jr. Hospital of Cook County | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Ambika Babu, MD 312-864-0543 Ambika_Babu@rush.edu | |
| Principal Investigator: Ambika Babu, MD | |
| Principal Investigator: | Ambika Babu, MD | John H Stroger Jr. Hospital of Cook County |
More Information
No publications provided
| Responsible Party: | Leon Fogelfeld, M.D., John H. Stroger Hospital |
| ClinicalTrials.gov Identifier: | NCT00852501 History of Changes |
| Other Study ID Numbers: | 06-044 |
| Study First Received: | February 26, 2009 |
| Last Updated: | April 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by John H. Stroger Hospital:
|
Non-functioning pituitary adenoma RTPCR Hormonal receptors |
Additional relevant MeSH terms:
|
Pituitary Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Hypothalamic Neoplasms Supratentorial Neoplasms Brain Neoplasms Central Nervous System Neoplasms |
Nervous System Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Hypothalamic Diseases Pituitary Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013