HealthyNCT00600652
FCM Analysis GR in Steroid-Treatment Patients
An observational study of Healthy, run by Changhai Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of SLE and NS
Who cannot join
- 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.
About this study
Official title: Flow Cytometric Analysis of Glucocorticoid Receptor Using Monoclonal Antibody and Fluoresceinated Ligand Probes in Glucocorticoid-Resistant and -Sensitive Patients
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.
Read the 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.
- Conditions
- Healthy
- Keywords
- glucocorticoid-receptor, flow cytometry, glucocorticoid-resistant, prediction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | glucocorticoid-resistant patients | |
| 2 | glucocorticoid-sensitive patients | |
| 3 | normal controls |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startDec 2006
- Primary completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jing Li, professor, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600652
- Sponsor's protocol ID
- 061210
- Other IDs
- 30730114
- Status last verified
- Jan 2008
- First submitted
- 15 Jan 2008
- Last updated
- 25 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Du J, Li M, Zhang D, Zhu X, Zhang W, Gu W, Feng Y, Zhai X, Ling C. Flow cytometry analysis of glucocorticoid receptor expression and binding in steroid-sensitive and steroid-resistant patients with systemic lupus erythematosus. Arthritis Res Ther. 2009;11(4):R108. doi: 10.1186/ar2763. Epub 2009 Jul 14.
PubMed 19594946
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow Cytometric Analysis of Glucocorticoid Receptor Using Monoclonal Antibody and Fluoresceinated Ligand Probes in Glucocorticoid-Resistant and -Sensitive Patients
- ClinicalTrials.gov ID
- NCT00600652
- Acronym / sponsor ID
- 061210
- Conditions
- Healthy
- Keywords
- glucocorticoid-receptor, flow cytometry, glucocorticoid-resistant, prediction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2010 (actual)
- First posted
- 25 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –glucocorticoid-resistant patients |
| 2 | – | –glucocorticoid-sensitive patients |
| 3 | – | –normal controls |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Clinical diagnosis of SLE and NS
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2008.
- Derived from this study: PubMed 19594946Du J, Li M, Zhang D, Zhu X, Zhang W, Gu W, Feng Y, Zhai X, Ling C. Flow cytometry analysis of glucocorticoid receptor expression and binding in steroid-sensitive and steroid-resistant patients with systemic lupus erythematosus. Arthritis Res Ther. 2009;11(4):R108. doi: 10.1186/ar2763. Epub 2009 Jul 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Li, professor principal investigator
Changhai Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Changhai Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00600652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2008.