Treatment Patterns and Treatment Outcomes for Acromegaly

Acromegaly Clinical Trial

Official title:

Treatment Patterns and Treatment Outcomes in a New York City Based Cohort of 520 Patients With Acromegaly

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03043586
• Other study ID #: AAAQ6709
• Status: Active, not recruiting
• Start date: December 2016
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a human, prospective and retrospective, single-center study of patients who have undergone treatment for acromegaly in New York City since 1981. The project will characterize, among other factors, the treatment methods received by patients, who administered the treatments and the success of this therapy in terms of biochemical control.

Description:

The first phase of this study will be to contact all subjects in the cohort by a mailing introducing them to the study. This will be followed by a phone call and administration of a questionnaire by phone or by mail. The questionnaire will collect current information on acromegaly treatment, morbidities other relevant history. Subjects will provide verbal consent to participate in this questionnaire part of the study and review of their medical records by the Principal Investigator (PI) and study staff.

In the second phase of the study, subjects will be invited to come for a visit that will be conducted by the PI and study staff at the Pituitary Center of Columbia University Irving Medical Center. At this visit written informed consent will be obtained. The investigators will review the subjects' medical history that is obtained from the subject and review any records and laboratory test results provided by the subject and conduct clinical and laboratory assessments. Although all subjects participating in Phase 1 will be invited to participate, it is estimated that 120 of the subjects invited will come for the one visit over the 2-year time frame of this study.

In the third phase of the study a chart review for collection will be conducted and all data will be compiled. All subjects agreeing to participate, both in person and by mail, a chart review of all relevant patient data including demographic, clinical, biochemical, surgical and follow up information. Data from questionnaires and record reviews will be compiled for analysis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 520
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult males and females.

• Ages 18 and over.

• Presenting to the PI or one of the sub-investigators for evaluation of acromegaly.

• Must be an Acromegaly subject that have undergone Pituitary surgery with Dr. Bruce or Dr. Post or Present it to principal investigator Dr. Pamela Freda at the Neuroendocrine Unit at Columbia University Medical Center for evaluation of Acromegaly.

Exclusion Criteria:

• Subjects who are unwilling to comply with the procedures outlined in the study.

• Subjects who do not have the ability to fully comprehend the nature of the study, to follow instructions, and/or cooperate with study procedures.

• Not being treated for acromegaly either by Dr. Bruce, Dr. Post or Dr. Freda.

• Are unwilling to provide informed consent to participate in the study.

Related Conditions & MeSH terms

• Acromegaly

Locations

Country	Name	City	State
United States	Neuroendocrine Unit at Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Ipsen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients that have received surgery as first line therapy	Frequency of each type of acromegaly therapy and rates of treatment by surgery alone, somatostatin analog, pegvisomant, radiotherapy and combinations of each of these therapies in the cohort will be recorded and determined. The expected result is that more than 90% of our cohort has received surgery as first line therapy and only a minority has received primary medical therapy.	At 5 years of therapy
Secondary	Number of patients with IGF-1 levels remaining elevated	This is to identify patients who are not optimally managed since their IGF-1 levels remain elevated.	At 5 years of therapy
Secondary	Hypertension Rate	This is to identify if hypertension is affected by how treatment is managed.	At 5 years of therapy
Secondary	Diabetes Mellitus Rate	This is to identify if diabetes mellitus is affected by how treatment is managed.	At 5 years of therapy
Secondary	Sleep Apnea Rate	This is to identify if sleep apnea is affected by how treatment is managed.	At 5 years of therapy