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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03379363

Enrollment

Registered

2017-12-20

Start date

2017-09-18

Completion date

2018-02-12

Last updated

2019-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cushing Syndrome, Hypercortisolism

Keywords

cushing syndrome, hypercortisolism

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 21 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results