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Tissue Samples and Bodily Fluid Specimens Banking

Sponsor
University of Tennessee (Other)
Overall Status
Completed
CT.gov ID
NCT02431884
Collaborator
(none)
200
Enrollment
1
Location
98.8
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to collect a portion of blood/tissue specimens that will be generated during the participants office visit or surgery. The investigators are asking whether a small portion of the specimen/s could be set aside and banked for future research purposes. Data originating from participants will be gathered and analyzed in research studies that will help understanding various medical conditions such as polycystic ovary syndrome (PCOS), congenital uterine malformations, endocrine malfunctions, endometriosis, and infertility.

Condition or Disease Intervention/Treatment Phase
  • Procedure: collect body fluids/tissues & med history

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Tissue and Bodily Fluid Specimens From Women Presenting to the Reproductive Endocrinology Clinic
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Mar 25, 2020
Actual Study Completion Date :
Mar 25, 2020

Arms and Interventions

Arm 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;

Procedure: collect body fluids/tissues & med history
collect tissues/fluids & history
Other Names:
  • disorders of the ovaries, uterus, endocrine, endometrium

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Specimen bank for future clinical research studies [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.]

      Creation of a blood serum/tissue specimens bank for future clinical research studies.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • females of childbearing potential experiencing reproductive endocrinology related problems.
    Exclusion Criteria:
    • male or female not of childbearing potential

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Regional One Health Ob-Gyn Clinic Memphis Tennessee United States 38103

    Sponsors and Collaborators

    • University of Tennessee

    Investigators

    • Principal Investigator: Laura Detti, M.D., Associate Professor, UTennessee Health Science Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Tennessee
    ClinicalTrials.gov Identifier:
    NCT02431884
    Other Study ID Numbers:
    • 11-01629-XP
    First Posted:
    May 1, 2015
    Last Update Posted:
    Nov 13, 2020
    Last Verified:
    Nov 1, 2020
    Additional relevant MeSH terms:
    Endocrine System Diseases

    Study Results

    No Results Posted as of Nov 13, 2020