FCM Analysis GR in Steroid-Treatment Patients

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. Identifier: NCT00600652
Recruitment Status : Unknown
Verified January 2008 by Changhai Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : January 25, 2008
Last Update Posted : January 25, 2008
Information provided by:
Changhai Hospital

Brief Summary:
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.

Condition or disease

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.

Study Type : Observational
Estimated Enrollment : 150 participants
Time Perspective: Prospective
Official Title: Flow Cytometric Analysis of Glucocorticoid Receptor Using Monoclonal Antibody and Fluoresceinated Ligand Probes in Glucocorticoid-Resistant and -Sensitive Patients
Study Start Date : December 2006
Actual Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
U.S. FDA Resources

glucocorticoid-resistant patients
glucocorticoid-sensitive patients
normal controls

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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.

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 identifier (NCT number): NCT00600652

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: ChangQuan Ling, Department of integrative medicien,Changhai Hospital Identifier: NCT00600652     History of Changes
Other Study ID Numbers: 061210
First Posted: January 25, 2008    Key Record Dates
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