NCT02663609

Brief Summary

Chart review study to collect patient data from medical charts of patients who have been treated with Korlym® for the treatment of ACTH independent adrenal Cushing's Syndrome.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

2.2 years

First QC Date

January 8, 2016

Last Update Submit

May 30, 2023

Conditions

Cushing's Syndrome

Keywords

Cushing's SyndromeMifepristoneAdrenalRetrospectiveChart Review

Outcome Measures

Primary Outcomes (1)

  • Drug Utilization Patterns as assessed by chart review

    The retrospective review would analyze the drug utilization patterns of patients treated with Korlym

    up to 4 years

Secondary Outcomes (1)

  • Clinical Outcomes as assessed by chart review

    up to 4 years

Interventions

No interventionOTHER

No treatment (intervention) was administered.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ACTH Independent Cushing's Syndrome patients treated with Korlym® mifepristone) as standard of care in clinical practice.

You may qualify if:

  • Diagnosed with ACTH independent endogenous Cushing's Syndrome
  • Available adrenal imaging prior to being treated with Korlym®
  • Treated with Korlym® and followed for at least 3 months (follow-up data should be available)

You may not qualify if:

  • Diagnosed with adrenocortical carcinoma
  • Participant in any clinical trial(s) during the observational period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cushing Syndrome

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2016

First Posted

January 26, 2016

Study Start

October 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

June 1, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share