Home
Search
Study Topics
Glossary
|
Descriptive Information Fields | |||||
---|---|---|---|---|---|
Brief Title † | Latent Viral Infection of Lymphoid Cells in Idiopathic Nephrotic Syndrome | ||||
Official Title † | Viral Infection of Lymphoid Cells Occuring at the First Manifestation of Idiopathic Nephrotic Syndrome | ||||
Brief Summary | The primary purpose of the study is to evaluate the association of a latent infection of lymphoid cells during the first manifestation of steroid sensitive nephrite syndrome. The thirty nine units of general pediatrics and pediatric nephrite covering the parisian area will participate to the study. We speculate that hybridization of the genome, or a part of the genome, of a virus in lymphoid cells is responsible specific changes of genes expression, leading to the development of the disease. |
||||
Detailed Description | An additional blood volume will be sampled in patients and controls during a scheduled biological check-up for the initial disease and viral genome of EBV, CMV, HHV6, HHV7 as well as adenovirus will be searched for using PCR reaction in total blood DNA extract. The frequency of a latent hybridization of virus genome within human genome will be compared between patients with steroid sensitive nephrotic syndrome and controls matched for age and sex. Secondary studies will include a comparison of steroid dependency in nephrotic patients according to the occurence of a latent viral hybridization, the epidemiology of idiopathic nephrotic syndrome in the Parisian area and a pharmacogenetic analysis of steroid sensitivity and dependency. If necessary, the chromosomal localization of viral hybridization will be studied with fluorescence in situ hybridization using specific probes. |
||||
Study Phase | |||||
Study Type † | Observational | ||||
Study Design † | Case Control, Prospective | ||||
Primary Outcome Measure † | Hybridization of viral genome will be studied at the first manifestation of idiopathic nephrotic syndrome [ Time Frame: Within the 3 days of the first manifestation ] [ Designated as safety issue: No ] | ||||
Secondary Outcome Measure † | Steroid sensitivity will be checked by 1 month of prednisone therapy according to the recommendation of the " SOCIETE DE NEPROLOGIE PEDIATRIQUE" and steroid dependency will be checked at 4.5 months of prednisone therapy. [ Time Frame: 4.5 months ] [ Designated as safety issue: No ] | ||||
Condition † | Nephrosis, Lipoid | ||||
Intervention † | |||||
MEDLINE PMIDs | 17855645, 17636340, 17554565, 16935903, 16267158, 16228184, 15882260, 15734130, 12814058, 12763891, 12761235, 12584259, 12478360, 12387184 | ||||
Links | |||||
Recruitment Information Fields | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 360 | ||||
Start Date † | December 2007 | ||||
Completion Date | November 2011 | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | 1 Year to 16 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
|
||||
Location Countries † | France | ||||
Administrative Information Fields | |||||
NCT ID † | NCT00577525 | ||||
Organization ID | P070126 | ||||
Secondary IDs †† | AOM 07018 | ||||
Study Sponsor † | Assistance Publique - Hôpitaux de Paris | ||||
Collaborators †† | |||||
Investigators † |
|
||||
Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
Verification Date | December 2008 | ||||
First Received Date † | December 19, 2007 | ||||
Last Updated Date | December 8, 2008 |