Clincosm LogoSign in Get a demo

FCM Analysis GR in Steroid-Treatment Patients

Sponsor
Changhai Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00600652
Collaborator
(none)
150
Enrollment

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated 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 :
    Dec 1, 2006
    Actual Primary Completion Date :
    Dec 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    1

    glucocorticoid-resistant patients
    2

    glucocorticoid-sensitive patients
    3

    normal controls

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      15 Years to 65 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Changhai Hospital

      Investigators

      • Principal Investigator: Jing Li, professor, Changhai Hospital

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00600652
      Other Study ID Numbers:
      • 061210
      • 30730114
      First Posted:
      Jan 25, 2008
      Last Update Posted:
      Jan 25, 2008
      Last Verified:
      Jan 1, 2008
      Keywords provided by , ,
      glucocorticoid-receptor
      flow cytometry
      glucocorticoid-resistant
      prediction

      Study Results

      No Results Posted as of Jan 25, 2008