Characterization of Receptors in Non-functioning Pituitary Macroadenomas
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | February 26, 2009 | ||||||||
| Last Updated Date | April 8, 2013 | ||||||||
| Start Date ICMJE | March 2006 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00852501 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Characterization of Receptors in Non-functioning Pituitary Macroadenomas | ||||||||
| Official Title ICMJE | Characterization of Receptors Present in Non-functioning Pituitary Macroadenomas by Reverse Transcriptase- Polymerase Chain Reaction (RT-PCR) | ||||||||
| Brief Summary | 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. |
||||||||
| 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. |
||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: A small piece of the pituitary macradenoma removed at surgery will be frozen to perform RT-PCR |
||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | All subjects who are diagnosed with a non-functioning pituitary macroadenoma who are scheduled for surgery. |
||||||||
| Condition ICMJE | Pituitary Tumor | ||||||||
| Intervention ICMJE | 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 |
||||||||
| Study Group/Cohort (s) | 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.
Intervention: Other: To perform RT-PCR on the tissue obtained during surgery |
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00852501 | ||||||||
| Other Study ID Numbers ICMJE | 06-044 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Leon Fogelfeld, John H. Stroger Hospital | ||||||||
| Study Sponsor ICMJE | John H. Stroger Hospital | ||||||||
| Collaborators ICMJE | University of Illinois | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | John H. Stroger Hospital | ||||||||
| Verification Date | April 2013 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||