- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02431884
Tissue Samples and Bodily Fluid Specimens Banking
Tissue and Bodily Fluid Specimens From Women Presenting to the Reproductive Endocrinology Clinic
Study Overview
Status
Intervention / Treatment
Detailed Description
PURPOSE: Women present to the Reproductive Endocrinology clinic with different concerns. These may involve conditions such as pelvic pain, endometriosis, Mullerian anomalies, polycystic ovary syndrome, abnormal uterine bleeding, menopausal symptoms, or infertility. Understanding the meaning of different biologic markers in their blood serum or tissues could help advancing the medical knowledge in the different conditions.
RATIONALE: To understand the meaning of different biologic markers in the patients' blood serum or tissue samples.
POPULATION: Patients identified among all women presenting to the reproductive endocrinology clinic.
Patients may undergo endometrial biopsy or surgery to evaluate their condition. In these instances, the investigators will ask the patients whether a small portion of their specimen/s could be collected and banked for future research purposes.
DESIGN: Prospective blood/tissue collection.
PROCEDURES: A small portion of the patient's blood or tissue specimen collected at the time of a medically indicated blood draw or surgical procedure will be collected and banked for future research purposes. Sample collection will be performed on existing specimens, once the specimens have been obtained for medical indications. No additional procedures will be performed on the patients for research purposes only.
OUTCOME MEASURES: Creation of a blood serum/tissue specimens bank for future clinical research studies.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tennessee
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Memphis, Tennessee, United States, 38103
- Regional One Health Ob-Gyn Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- females of childbearing potential experiencing reproductive endocrinology related problems.
Exclusion Criteria:
- male or female not of childbearing potential
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
body fluids/tissues & history
collect body fluids/tissues & med history from subjects with polycystic ovary syndrome(PCOS), congenital uterine malformations, endocrine malfunctions, endometriosis, and infertility;
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collect tissues/fluids & history
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Specimen bank for future clinical research studies
Time Frame: The samples collected during the clinical visit will be preserved and maintained as frozen specimens until the research is performed, which may occur from: within 1 year, and up to 24 years after collection.
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Creation of a blood serum/tissue specimens bank for future clinical research studies.
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The samples collected during the clinical visit will be preserved and maintained as frozen specimens until the research is performed, which may occur from: within 1 year, and up to 24 years after collection.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laura Detti, M.D., Associate Professor, UTennessee Health Science Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-01629-XP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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