Cushing's SyndromeRE-KLAIMNCT02663609
Retrospective Chart Review Study of Korlym for the Treatment of ACTH Independent Cushing's Syndrome
An observational study of Cushing's Syndrome, run by Corcept Therapeutics.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cushing's Syndrome
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ACTH Independent Cushing's Syndrome patients treated with Korlym® mifepristone) as standard of care in clinical practice.
Who may be able to join
- 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)
Who cannot join
- Diagnosed with adrenocortical carcinoma
- Participant in any clinical trial(s) during the observational period
About this study
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.
Read the detailed description
A retrospective, multi-center, 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. Treatment with Korlym® will be a minimum 3 months in duration with follow-up of a minimum 3 months. Only sites that have been identified to have patients appropriate for this protocol will be invited to participate.
- Conditions
- Cushing's Syndrome
- Being tested
- No intervention
- Keywords
- Cushing's Syndrome, Mifepristone, Adrenal, Retrospective, Chart Review
- Medical subject headings
- Cushing Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No treatment (intervention) was administered.
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Utilization Patterns as assessed by chart review
The retrospective review would analyze the drug utilization patterns of patients treated with Korlym
Measured: up to 4 years
Secondary outcomes (1)
Clinical Outcomes as assessed by chart review
The retrospective review would analyze outcomes measures (vitals, clinical assessments, etc) in patients treated with Korlym
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startOct 2015
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663609
- Sponsor's protocol ID
- C1073-450
- Acronym
- RE-KLAIM
- Status last verified
- May 2023
- First submitted
- 8 Jan 2016
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Chart Review Study of Korlym for the Treatment of ACTH Independent Cushing's Syndrome
- ClinicalTrials.gov ID
- NCT02663609
- Acronym / sponsor ID
- RE-KLAIM / C1073-450
- Conditions
- Cushing's Syndrome
- Keywords
- Cushing's Syndrome, Mifepristone, Adrenal, Retrospective, Chart Review
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A retrospective, multi-center, 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. Treatment with Korlym® will be a minimum 3 months in duration with follow-up of a minimum 3 months. Only sites that have been identified to have patients appropriate for this protocol will be invited to participate.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ACTH Independent Cushing's Syndrome patients treated with Korlym® mifepristone) as standard of care in clinical practice.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Diagnosed with adrenocortical carcinoma
- Participant in any clinical trial(s) during the observational period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo treatment (intervention) was administered. | Other | – |
Primary outcome
Drug Utilization Patterns as assessed by chart review
Time frame: up to 4 years
The retrospective review would analyze the drug utilization patterns of patients treated with Korlym
1 secondary outcome
Clinical Outcomes as assessed by chart review
Time frame: up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cushing's Syndrome, run by Corcept Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug Utilization Patterns as assessed by chart review (time frame: up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.