Clinical Trials & Surveys
“Those of us with adrenal disease know the importance of having new treatments that will give us an opportunity to have the best quality of life with improved medical options. Participation in clinical trials can help accelerate the development of new treatments and address our community’s unmet medical needs.”
For further information on these and other trials, go to clinicaltrials.gov.
All clinical trials listed below are for informational purposes only. NADF does not endorse these or any products.
Currently Recruiting Clinical Trials for Adrenal Diseases
Evaluating the Functional Status of the Adrenal Glands Hyperaldosteronism
Objective of this study is to see if a new radioactive tracer ([68Ga]Ga-PentixaFor) can make it easier to identify functional adrenal tumors leading to hyperaldosteronism.
Sponsor: National Cancer Institute
Principal Investigator:
Maria Liza Lindenberg, M.D.
Phone Number: (240) 760-6109
Email: liza.lindenberg@mail.nih.gov
Who should consider participation: People aged 18 years and older with 1 or more adrenal tumors. They must have increased levels of the hormone aldosterone.
Updated Diagnostic Cortisol Values for Adrenal Insufficiency
The purpose of this study is to determine the cortisol levels that most accurately diagnose a patient with adrenal insufficiency, a condition in which cortisol levels are too low for daily living.
Sponsor: Montefiore Medical Center
Contact: Smita B. Abraham, MD; email: smabraham@montefiore.org
Who should consider participating: If you are a male or a female, 18 years or older, consider participation to help determine the appropriate level of cortisol in healthy individuals to allow a more accurate diagnosis of people with adrenal insufficiency.
MyAI: Cortisol and Function Study
Recruitment is currently on hold.
Adrenal insufficiency is an uncommon disease that results in a lack of critical hormones. Replacement of the hormones is a complex issue due to difficulty replicating normal secretion patterns and individual variation in how the drugs are absorbed and metabolized. NADF has funded this study, conducted by researchers at National Jewish Health, in order to better understand the relationship between measured cortisol levels and the symptoms associated with adrenal insufficiency.
We are seeking people age 18+ with adrenal insufficiency who can provide blood and saliva samples over a six hour time period to measure cortisol levels over time after they take their medication. In addition to blood samples, the study will involve some short questionnaires, measuring blood and heart rate, and a brief strength test.
Study participants must be on a stable dose of hydrocortisone replacement therapy and be able to travel to National Jewish Health in Denver, CO.
MyAI: DNA and Cortisol Study
Recruitment for this study is currently on hold.
The MyAI Registry participants are invited to enroll into the DNA and Cortisol studies. There is no cost to participate in either study, and you may choose to participate in both. You will be provided with the sampling kits, mailing containers, and shipping labels.
The genetic factors related to adrenal insufficiency (AI) are not well characterized. A few people may have clear associations to genetic factors but others do not, and there is evidence that family members of AI patients may be at increased risk of disease. People also vary in the severity of symptoms and risk of crisis. We want to study possible genetic factors related to adrenal disease. In addition, we'd like to better understand how cortisol levels might be used to evaluate your replacement dosing.
Bio-sample option 1: Participants will be mailed a mouth swab kit in order to collect cells from the inside of their cheek. DNA will then be extracted from these cells for research use.
Bio-sample option 2: Participants will be mailed three collection tubes to collect saliva at specific times of day and record symptoms at the time of collection. We will then test the free cortisol levels in the saliva.
Maintaining the integrity of the samples is critical, so we ask people to only enroll in these studies if they are able to carefully follow the instructions and are able to mail the samples back to the study according to the provided instructions.
Pharmacokinetic (PK), Pharmacodynamic (PD), and Tolerability of Osilodrostat in Pediatric Patients with Cushing’s Syndrome
Is your child suffering from Cushing’s syndrome? You may consider their participation in LINC-5 study which evaluates the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing's syndrome.
Sponsor: Recordati Rare Diseases
Contact:
Dr. Maya Lodish maya.lodish@ucsf.edu, University of California San Francisco, CA
Dr. Cristina Tatsi christina.tatsi3@nih.gov, National Institute of Child Health & Human Development, MD
Who should consider participating: Children and adolescents 2 to <18 years of age with Cushing’s syndrome may qualify to participate in the LINC-5 study