Advanced Biomarker Assessment in Pelvic Organ Prolapse

NCT ID: NCT03642054

Last Updated: 2021-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-29

Study Completion Date

2020-05-18

Brief Summary

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This study will assess advanced biomarkers in patients with and without vaginal prolapse. Assessments will be directed at vaginal fibroblasts and adipose derived stem cells.

Detailed Description

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Vaginal biopsies and abdominal adipose harvest will be accomplished in patients undergoing vaginal hysterectomy for non-prolapse benign conditions (6) and pelvic organ prolapse (6). Samples of tissues will be divided and portions will be snap-frozen, placed into transport medium for subsequent tissue digestion, and receive paraffin processing. Cells in transport medium will be transported to the Mayo Collaborative Research building (lab of Dr. David Lott) for isolation of fibroblasts and adipose derived stem cells.

The other samples will be transported to the lab of Dr. Andre van Wijnen (RST) to isolate RNA and protein for mRNA, microRNA and additional protein analysis.

Isolated fibroblasts and ASC's from the lab of Dr. Lott (MCA) will be expanded and passaged 3-5 times. ASCs phenotype will be confirmed by flow cytometry. Cells lines will be duplicated and biobanked at the Mayo Clinic Rochester Biotrust and separately biobanked at the Arizona State University lab of scaffold collaborator, Dr. Stephen Massia. Additional frozen cell lines will transported to the lab of Dr. Andre van Wijnen for further processing. . All cells and materials will be used for testing and to advance the science of regenerative medicine. No biobanked cells or materials from this specific project will be used for any future intervention or treatment in humans.

Conditions

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Pelvic Organ Prolapse

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Pelvic Organ Prolapse

Patients having vaginal hysterectomy who demonstrate grade III-IV uterovaginal prolapse.

No interventions assigned to this group

Non Pelvic Organ Prolapse

Patients having vaginal hysterectomy who do not demonstrate uterovaginal prolapse.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing vaginal hysterectomy for non-prolapse benign conditions and pelvic organ prolapse
* at least 18 years old
* Mayo Clinic patient

Exclusion Criteria

°Patients who have a history of a recognized classic connective tissue disease
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Johnny Yi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Johnny Yi, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Phoenix, Arizona, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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17-009172

Identifier Type: -

Identifier Source: org_study_id

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