Treatment Patterns and Treatment Outcomes for Acromegaly

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
Related Clinical Trial
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Brief Title

Treatment Patterns and Treatment Outcomes for Acromegaly

Official Title

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

Brief 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.

Detailed 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.

Study Type

Observational

Primary Outcome

Percentage of patients that have received surgery as first line therapy

Secondary Outcome

 Number of patients with IGF-1 levels remaining elevated

Condition

Acromegaly

Study Arms / Comparison Groups

 Treatment Pattern
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. A phone script will be utilized to obtain verbal informed consent from subjects for this phase of the study. The questionnaire will collect current information on acromegaly treatment, morbidities and 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 PI and study staff.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

520

Start Date

December 2016

Completion Date

July 2023

Primary Completion Date

July 2023

Eligibility Criteria

        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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Pamela U Freda, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03043586

Organization ID

AAAQ6709

Responsible Party

Principal Investigator

Study Sponsor

Columbia University

Collaborators

 Ipsen

Study Sponsor

Pamela U Freda, MD, Principal Investigator, Columbia University

Verification Date

October 2022