Retrospective Chart Review Study of Pediatric Patients Treated With Korlym for Cushing Syndrome

July 26, 2019 updated by: Corcept Therapeutics
This retrospective, multi-center, chart review study will collect patient data from medical charts of pediatric patients who have been treated with Korlym for Cushing's syndrome.

Study Overview

Status

Terminated

Detailed Description

This retrospective chart review study seeks to collect data from pediatric patients treated with Korlym (mifepristone) to help provide clinicians with some insight on the potential role of mifepristone in the treatment of pediatric patients with Cushing syndrome.

Only sites that have been identified to have patients appropriate for this protocol will be invited to participate and contribute data on their patients

Data to be collected from a retrospective chart review will include:

  • Patient demographics
  • Medical history
  • Pre and post treatment clinical assessments and laboratory results
  • Radiologic findings (if available)
  • Adverse events

Data will be collected for all follow-up visits, up until the most recent encounter prior to IRB approval.

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Menlo Park, California, United States, 94025
        • Corcept Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients who have been treated with Korlym for Cushing's syndrome

Description

Inclusion Criteria:

  • Pediatrics (age≤21 years) at time Korlym initiation
  • Considered to have a diagnosis of endogenous Cushing's syndrome by the healthcare provider
  • Received at least one dose of Korlym
  • Availability of pre-treatment (baseline) and follow-up data

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Pediatric Cushing Syndrome Patients
Pediatrics patients with endogenous Cushing syndrome who received at least one dose of Korlym

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug utilization patterns as assessed by chart review
Time Frame: Length of Korlym therapy, up to 5 years
The retrospective review would analyze the drug utilization patterns of pediatric patients treated with Korlym
Length of Korlym therapy, up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight as assessed by chart review
Time Frame: Length of Korlym therapy, up to 5 years
The retrospective review would analyze changes in Weight (in kg) in pediatric patients treated with Korlym
Length of Korlym therapy, up to 5 years
Blood Pressure as assessed by chart review
Time Frame: Length of Korlym therapy, up to 5 years
The retrospective review would analyze changes in Blood Pressure (in mmHg) in pediatric patients treated with Korlym
Length of Korlym therapy, up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2017

Primary Completion (Actual)

February 12, 2018

Study Completion (Actual)

February 12, 2018

Study Registration Dates

First Submitted

October 24, 2017

First Submitted That Met QC Criteria

December 18, 2017

First Posted (Actual)

December 20, 2017

Study Record Updates

Last Update Posted (Actual)

July 30, 2019

Last Update Submitted That Met QC Criteria

July 26, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cushing Syndrome

3
Subscribe