Prospective Assessment in Newborns for Diabetes Autoimmunity (PANDA)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Georgia Regents University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Georgia Regents University
Collaborators:
University of Florida
Emory University
Medical University of South Carolina
University of South Carolina
Information provided by:
Georgia Regents University
ClinicalTrials.gov Identifier:
NCT00649246
First received: March 28, 2008
Last updated: May 12, 2011
Last verified: May 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 28, 2008 | ||||||||
| Last Updated Date | May 12, 2011 | ||||||||
| Start Date ICMJE | July 1997 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
autoantibodies against the pancreas and type 1 diabetes [ Time Frame: 50 years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00649246 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Risk factors for type 1 diabetes [ Time Frame: 50 years ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Prospective Assessment in Newborns for Diabetes Autoimmunity | ||||||||
| Official Title ICMJE | 1. Prospective Studies in Infants of the Immunopathogenesis of Type 1 Diabetes 2. Consortium for Identification of Environmental Triggers of Type 1 Diabetes: MCG/UF Clinical Center 3. Identification of Serum Protein Markers for Type 1 Diabetes Using Mass-Spectrometry Techniques 4. Validation of Microarray-Based Biomarkers for Type 1 Diabetes 5. Development of Microarray-Based Biomarkers for Type 1 Diabetes 6. Proteomic Changes/Progression of Human Type 1 Diabetes 7. Identification and Validation of Serum Biomarkers for T1D | ||||||||
| Brief Summary | This is an observational study designed to help researchers understand the genetics and pathogenesis of type 1 diabetes, and to identify biomarkers for disease and disease complication prediction. |
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| Detailed Description | This study is designed to identify people who are at risk for developing type 1 diabetes, based on their genetics, family history and autoimmunity status, and to understand the role genetics plays in the development of the complications associated with type 1 diabetes in patients already affected by type 1 diabetes. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: whole blood, DNA, serum, RNA, urine |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | newborns, young children, adults with or without type 1 diabetes |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50000 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: all are welcome - Exclusion Criteria: - |
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00649246 | ||||||||
| Other Study ID Numbers ICMJE | DK63865 - PANDA, U01DK063865 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Jin Xiong She Ph.D., Center for Biotechnology and Genomic Medicine at the Medical College of Georgia | ||||||||
| Study Sponsor ICMJE | Georgia Regents University | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Georgia Regents University | ||||||||
| Verification Date | May 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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