Human Epididymis Protein 4 in Normal Menstruating Women
This study is currently recruiting participants.
Verified June 2013 by Women and Infants Hospital of Rhode Island
Sponsor:
Women and Infants Hospital of Rhode Island
Collaborator:
Abbott
Information provided by (Responsible Party):
Beth Plante, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT01337999
First received: April 15, 2011
Last updated: June 12, 2013
Last verified: June 2013
| Tracking Information | |||||
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| First Received Date ICMJE | April 15, 2011 | ||||
| Last Updated Date | June 12, 2013 | ||||
| Start Date ICMJE | March 2011 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
HE-4 level [ Time Frame: 5 times during menstrual cycle ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01337999 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 | Human Epididymis Protein 4 in Normal Menstruating Women | ||||
| Official Title ICMJE | Human Epididymis Protein 4 in Normal Menstruating Women | ||||
| Brief Summary | The purpose of this study is to determine if Human Epididymis Protein 4 (HE-4) levels vary during the menstrual cycles in ovulatory women. HE-4 is a sensitive serological marker that is elevated in certain ovarian and endometrial cancers and can aid in the diagnosis of these malignant conditions. In order to optimize the utility of HE4 as a tumor marker in premenopausal women, its expression in the normal menstrual cycle needs to be characterized. We hypothesize that HE-4 levels do not vary in the menstrual cycle. |
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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 With DNA Description: Serum |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Ovulating women recruited from local college campuses, doctor's offices and hospitals. |
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| Condition ICMJE | Healthy Premenopausal Women | ||||
| Intervention ICMJE | Other: blood draws
5 blood draws during ovulatory menstrual cycles in premenopausal women |
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| Study Group/Cohort (s) | HE-4 levels, healthy premenopausal women
Intervention: Other: blood draws |
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| Publications * |
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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 | 60 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01337999 | ||||
| Other Study ID Numbers ICMJE | 10-0127 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Beth Plante, Women and Infants Hospital of Rhode Island | ||||
| Study Sponsor ICMJE | Women and Infants Hospital of Rhode Island | ||||
| Collaborators ICMJE | Abbott | ||||
| Investigators ICMJE |
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| Information Provided By | Women and Infants Hospital of Rhode Island | ||||
| Verification Date | June 2013 | ||||
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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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