Fecal Calprotectin in Cystic Fibrosis
This study is ongoing, but not recruiting participants.
Sponsor:
Medical College of Wisconsin
Information provided by (Responsible Party):
Steve Werlin, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00863694
First received: March 16, 2009
Last updated: May 14, 2012
Last verified: May 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 16, 2009 | ||||
| Last Updated Date | May 14, 2012 | ||||
| Start Date ICMJE | February 2009 | ||||
| Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
collection of 150 stool specimens [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00863694 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Fecal Calprotectin in Cystic Fibrosis | ||||
| Official Title ICMJE | Fecal Calprotectin in Cystic Fibrosis | ||||
| Brief Summary | Elevated fecal calprotectin is a biomarker for intestinal inflammation in cystic fibrosis |
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| Detailed Description | Not Provided | ||||
| 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 Without DNA Description: stool |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients attending the cystic fibrosis clinics at the Children's Hospital of Wisconsin and Froedtert Hospital |
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| Condition ICMJE | Cystic Fibrosis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| 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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Estimated Completion Date | February 2014 | ||||
| Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 1 Month and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00863694 | ||||
| Other Study ID Numbers ICMJE | calpro | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Steve Werlin, Medical College of Wisconsin | ||||
| Study Sponsor ICMJE | Medical College of Wisconsin | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Medical College of Wisconsin | ||||
| Verification Date | May 2012 | ||||
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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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