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FCM Analysis GR in Steroid-Treatment Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2008 by Changhai Hospital.
Recruitment status was:  Enrolling by invitation
ClinicalTrials.gov Identifier:
First Posted: January 25, 2008
Last Update Posted: January 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Changhai Hospital
Monitoring the GR with a GR-MoAb and FITC-Dex probes by FCM would be useful and convenient in determination GR before the steroid treatment in clinical, especially in steroid resistant states, in order to design more efficient clinical treatment protocols.


Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Flow Cytometric Analysis of Glucocorticoid Receptor Using Monoclonal Antibody and Fluoresceinated Ligand Probes in Glucocorticoid-Resistant and -Sensitive Patients

Resource links provided by NLM:

Further study details as provided by Changhai Hospital:

Biospecimen Retention:   Samples With DNA
introcellular and exocellular proteins in peripheral blood mononuclear cells of subjects

Estimated Enrollment: 150
Study Start Date: December 2006
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
glucocorticoid-resistant patients
glucocorticoid-sensitive patients
normal controls

Detailed Description:
In order to assess the efficacy of this method, 100 patients with nephrotic syndrome and systemic lupus erythematosus receiving sufficient prednisolone thereafter and 50 age- and sex-matched normal controls will be studied.

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
one hundred patients, including 50 SLE and 50 NS, who will receive GC therapy, were studied. Of them, fifty were GC-resistant patients (25 male and 25 female; 20 without treatment and 30 relapse) and fifty were GC-sensitive ones( 25 male and 25 female; 20 without treatment and 30 relapse ). Controls were 50 healthy volunteers (25 male and 25 female). All participants gave their informed consent, and this investigation was approved by Changhai hoapital ethics committee.

Inclusion Criteria:

  • Clinical diagnosis of SLE and NS

Exclusion Criteria:

  • Receiving hormone replacement therapy or had received hormone replacement therapy in three months before start of the study
  • Received drugs or drinks containing alcohol within one month
  • Having symptom such as infection
  • Supersensitivity and endocrine disturbance.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00600652

Sponsors and Collaborators
Changhai Hospital
Principal Investigator: Jing Li, professor Changhai Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ChangQuan Ling, Department of integrative medicien,Changhai Hospital
ClinicalTrials.gov Identifier: NCT00600652     History of Changes
Other Study ID Numbers: 061210
First Submitted: January 15, 2008
First Posted: January 25, 2008
Last Update Posted: January 25, 2008
Last Verified: January 2008

Keywords provided by Changhai Hospital:
flow cytometry

Additional relevant MeSH terms:
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs