Recruiting

Observational Study

Sponsor:

Cook County Health

Code:

NCT00852501

Conditions

Pituitary Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

To perform RT-PCR on the tissue obtained during surgery

Study Details

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.

Conditions

Pituitary Tumor

Study ID

NCT00852501

Start date

Mar, 2006

Status verified date

Apr, 2013

Completion date

Dec, 2013

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adults, both males and females age 18 years old or more
2. Pituitary tumor more than 10 mm in diameter diagnosed by MRI
3. No clinical or laboratory evidence of pituitary hormone oversecretion (non-functioning pituitary macroadenoma)

Exclusion Criteria:

1. Subjects with pituitary tumors less than 10 mm in diameter
2. Subjects with clinical or laboratory evidence of hormone oversecretion
3. Presence of dementia

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • To determine the expression of hormonal receptors in clinically non-functioning pituitary macroadenomas by RT - PCR and immunohistochemistry. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Ambika Babu, MD

312 864 0543Ambika_Babu@rush.edu

Leon A Fogelfeld, MD

312 864 0540lfogelfe@cchil.org

Locations

John H Stroger Jr. Hospital of Cook County

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Ambika Babu, MD

312-864-0543Ambika_Babu@rush.edu

Principal Investigator:

Ambika Babu, MD

More Information

Sponsor

Cook County Health

Last update posted

Apr 9, 2013

Last verified

Apr, 2013

Keywords

  • Non-functioning pituitary adenoma
  • RTPCR
  • Hormonal receptors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cook County Health on 2013-04-09.