Patient clinical trials

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Columbia University is one of the premier endocrine surgery programs in the country. Our innovative research continues to advance our understanding of endocrine diseases and improve the care of our patients. As a multidisciplinary center, we have several ongoing clinical trials, some of which are listed below. 

SLEEP AND COGNITION IN PRIMARY HYPERPARATHYROIDISM (SHH STUDY)  Study Investigators: James A. Lee MD, (Primary), Jennifer H. Kuo MD MS, Catherine McManus MD MS, Marcella Walker MD    

The goal of this study is to learn whether sleep quality, brain function, and mood improve after surgery in patients with primary hyperparathyroidism (PHPT) and certain types of thyroid disease.    We will assess sleep quality with a test for sleep apnea and actigraphy (a non-invasive test that involves wearing a watch while you sleep). We will also evaluate brain function with brief verbal tests of memory.  Finally, we will see if sleep quality improves after parathyroidectomy and if its improvement is associated with changes in brain function.   Potential participants may be approached by their treating doctor and if permission is granted, they will be contacted by the study coordinator. Once a participant agrees to be contacted, we will call the participant and screen for eligibility with our screening questionnaire.   

Please contact 929-265-8993 or da2902@cumc.columbia.edu if you are interested. 

QUALITY OF LIFE MEASURES AFTER TREATMENT OF BENIGN THYROID NODULES 

Study Investigators: Jennifer H. Kuo, MD MS (Primary), James A. Lee MD, Catherine McManus MD MS Funding Source: ThyCA / American Thyroid Association   

A prospective cohort study evaluating quality of life measures after RFA for benign multinodular goiter. All adult patients >/=18 years of age who present to the Columbia Thyroid Center with benign symptomatic goiter will be eligible for enrollment. Participants who elect to undergo RFA for treatment will be compared to those who elect observation or surgery.  

CLINICAL OUTCOMES AFTER RADIOFREQUENCY ABLATION OR ACTIVE SURVEILLANCE OF PAPILLARY MICROCARCINOMA 

Study Investigators: Jennifer H. Kuo, MD MS (Primary), James A. Lee MD, Catherine McManus MD MS Funding Source: ThyCA / American Thyroid Association  

A single institution randomized controlled trial evaluating clinical outcomes after RFA vs active surveillance (AS) for papillary microcarcinoma (mPTC). All adult patients >/=18 years of age with a biopsy proven papillary thyroid cancer </=1.5cm who opt in for the active surveillance program at the Columbia Thyroid Center will be eligible for enrollment in the study.  

CLINICAL OUTCOMES AFTER RADIOFREQUENCY ABLATION OF INDETERMINATE (BETHESDA III) NODULES, CLASSIFIED BENIGN 

Study Investigators: Jennifer H. Kuo, MD MS (Primary), James A. Lee MD, Catherine McManus MD MS Funding Source: ThyCA / American Thyroid Association  

A single institution prospective cohort study evaluating clinical outcomes after RFA for indeterminate thyroid nodules that have been molecular profiled benign. All adult patients >/=18 years of age who present to the Columbia Thyroid Center with an indeterminate nodule demonstrating atypical cytology or follicular lesion of unknown significance (Bethesda III) that has been molecularly profiled as benign,  will be eligible for enrollment in the study. Participants who elect to undergo RFA for treatment will be compared to those who elect observation or surgery.          

ASSESSMENT OF QUALITY OF LIFE FOR PATIENTS WITH PRIMARY HYPERPARATHYROIDISM 

Study Investigators: Catherine McManus MD MS, (Primary), James A. Lee MD, Jennifer H. Kuo MD MS   A single institution prospective cohort study evaluating how primary hyperparathyroidism impacts quality of life, and more specifically determine what symptoms improve after surgery and to what degree. All adult  patients >/=18 years of age who present to the Columbia Parathyroid Center for treatment of primary hyperparathyroidism are eligible to participate. The study consists of participating in three interviews (zoom or in person) ~30 minutes long to discuss your symptoms in depth: one prior to surgery and two postoperatively at 1 and 6 months.    

ATENOLOL FOR THE PREVENTION OF OSTEOPOROSIS (APO) STUDY 

Study Investigators: Marcella Walker MD, (Primary), James A. Lee MD, Jennifer H. Kuo MD MS, Catherine McManus MD MS  

The goal of this study is to learn whether treatment with a safe, commonly used drug called ATENOLOL prevents bone loss in women after menopause.    WHO QUALIFIES? 

•       Healthy post-menopausal women who are between the ages of 50 and 75. 

•       You may not be eligible if you have certain medical  conditions. WHAT’S INVOLVED? 

•       If you are eligible, you will be assigned randomly to take a pill that may be either atenolol or a placebo.  

•       If you join this study ,  you will have 6 study visits to CUIMC over 2 years. 

VISIT PROCEDURES INCLUDE: 

•       Measure heart rate and blood pressure. 

•       Questionnaires about health and diet. 

•       A DXA scan to measure Bone Density. 

•       A Bone Quality scan to measure strength of your wrist and ankle bones. 

•       A blood test for bone markers.   

All tests will be free of charge. If you join, you will be compensated for your time and travel.  Please contact 212-305-7225 or BoneResearch@cumc.columbia.edu if you are interested.