NCT00796783

Brief Summary

This is an observational study to confirm the presence of recurrent or persistent endogenous Cushing's syndrome in patients who have had primary surgical and/or radiation therapy for Cushing's disease and continue to manifest symptoms and signs of hypercortisolemia.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

3 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Last Updated

June 20, 2014

Status Verified

June 1, 2014

Enrollment Period

1.3 years

First QC Date

November 20, 2008

Last Update Submit

June 19, 2014

Conditions

Cushing's Syndrome

Keywords

Cushing's DiseaseCushing's SyndromeCushingsPituitaryACTHAdrenocorticotropic hormoneEctopicAdrenal adenomaAdrenal carcinomaAdrenal autonomyCortisolHypercortisolemiaCushinoidMoon faciesDorsalcervical fatPlethoraHirsutismViolaceous striaeHormoneContraceptiveEndocrineCushing SyndromeEctopic ACTH Secretion

Outcome Measures

Primary Outcomes (1)

  • To confirm the presence of recurrent or persistent endogenous Cushing's syndrome in patients who have had primary surgical and/or radiation therapy for Cushing's disease and continue to manifest symptoms and signs of hypercortisolemia.

    up to 16 weeks

Study Arms (1)

1

Patients with presumed Cushing's disease who have failed pituitary surgery and/or radiation and require medical treatment for recurrent or persistent Cushing's syndrome.

Drug: Cushing's syndrome confirmation

Interventions

Cushing's syndrome confirmationDRUG
Also known as: Provide access to standard test procedures.
1

Eligibility Criteria

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

Patients with presumed Cushing's disease who have failed pituitary surgery and/or radiation and require adjuvant medical treatment for recurrent or persistent Cushing's syndrome.

You may qualify if:

  • Are at least 18 years of age.
  • Have a presumptive diagnosis of Cushing's disease (Cushing's syndrome due to an ACTH secreting pituitary tumor).
  • Have previously had pituitary surgery and/or pituitary radiation with the intent of curing or treating Cushing's disease.
  • Have clinical symptoms and signs of hypercortisolism.
  • Are able to provide written informed consent.
  • Are expected to complete the study.

You may not qualify if:

  • Are surgical candidates for pituitary surgery or have had pituitary surgery within 8 weeks before screening.
  • Have taken any medication that may interfere with protocol testing procedures within 30 days of initial screening (phenobarbital, phenytoin, carbamazepine, oxcarabazepine, primidone, rifampin, rifapentine, rifabutin, ethosuximide, pioglitazone, efavirenz, neviparine, modafinil, St. Johns wort, glucorticoids, estrogen containing oral contraceptives).
  • Have received investigational treatment (drug, biologic agent or device) within 30 days of screening.
  • Have a non-endogenous source of hypercortisolemia such as factitious hypercortisolemia (exogenous source of glucocorticoid, iatrogenic Cushing's syndrome), factitious or therapeutic use of ACTH.
  • Have Pseudo-Cushing's syndrome. Subjects with suspected Pseudo-Cushing's syndrome such as those with severe obesity, major depression or a history of alcoholism.
  • Uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
  • Have renal failure as defined by a serum creatinine of 202 mg/dL.
  • Elevated total bilirubin (\>1.5x ULN), elevated ALT(\>3x ULN) or AST (\>3x ULN).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

AMCR Institute Inc.

Escondido, California, 92026, United States

Location

The Center for Diabetes and Endocrine Care

Hollywood, Florida, 33021, United States

Location

Diabetes and Glandular Disease Research

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Cushing SyndromePituitary ACTH HypersecretionPituitary DiseasesChoristomaACTH Syndrome, EctopicAdrenal Cortex NeoplasmsHirsutism

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System DiseasesHyperpituitarismHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsParaneoplastic Endocrine SyndromesParaneoplastic SyndromesNeoplasmsAdrenal Gland NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteAdrenal Cortex DiseasesHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesVirilismSigns and Symptoms

Study Officials

  • Coleman Gross, MD

    Corcept Therapeutics

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 20, 2008

First Posted

November 24, 2008

Study Start

February 1, 2009

Primary Completion

June 1, 2010

Last Updated

June 20, 2014

Record last verified: 2014-06

Locations

US(3)