FCM Analysis GR in Steroid-Treatment Patients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Changhai Hospital
ClinicalTrials.gov Identifier:
NCT00600652
First received: January 15, 2008
Last updated: January 24, 2008
Last verified: January 2008
  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

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)
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
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, see Learn About Clinical Studies.

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 by Changhai Hospital

Additional 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, 30730114
Study First Received: January 15, 2008
Last Updated: January 24, 2008
Health Authority: China: Ethics Committee

Keywords provided by Changhai Hospital:
glucocorticoid-receptor
flow cytometry
glucocorticoid-resistant
prediction

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

ClinicalTrials.gov processed this record on October 22, 2014