FCM Analysis GR in Steroid-Treatment Patients

This study is enrolling participants by invitation only.

First Received: January 15, 2008 Last Updated: January 24, 2008 History of Changes

Sponsored by:	Changhai Hospital
Information provided by:	Changhai Hospital
ClinicalTrials.gov Identifier:	NCT00600652

Purpose

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
Healthy

U.S. FDA Resources

Study Type:

Observational

Study Design:

Prospective

Official Title:

Flow Cytometric Analysis of Glucocorticoid Receptor Using Monoclonal Antibody and Fluoresceinated Ligand Probes in Glucocorticoid-Resistant and

Sensitive Patients

Further study details as provided by Changhai Hospital:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

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)

Groups/Cohorts
1 glucocorticoid-resistant patients
2 glucocorticoid-sensitive patients
3 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.

Eligibility

Ages Eligible for Study:	15 Years to 65 Years
Genders Eligible for Study:	Both
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.

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600652

Sponsors and Collaborators

Changhai Hospital

Investigators

Principal Investigator:

Jing Li, professor

Changhai Hospital

More Information

No publications provided

Responsible Party:	Department of integrative medicien,Changhai Hospital ( ChangQuan Ling )
Study ID Numbers:	061210, 30730114
Study First Received:	January 15, 2008
Last Updated:	January 24, 2008
ClinicalTrials.gov Identifier:	NCT00600652 History of Changes
Health Authority:	China: Ethics Committee

Keywords provided by Changhai Hospital:

glucocorticoid-receptor
flow cytometry
glucocorticoid-resistant
prediction

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

Healthy
Hormones
Glucocorticoids
Immunoglobulins

Additional relevant MeSH terms:

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009