Pelvic Organ ProlapseNCT03642054
Advanced Biomarker Assessment in Pelvic Organ Prolapse
An observational study of Pelvic Organ Prolapse, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- Type of treatment
- Injection or infusion
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2018to 18 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 6 patients with pelvic organ prolapse and 6 patients without pelvic organ prolapse.
Who may be able to join
- Patients undergoing vaginal hysterectomy for non-prolapse benign conditions and pelvic organ prolapse
- at least 18 years old
- Mayo Clinic patient
Who cannot join
- °Patients who have a history of a recognized classic connective tissue disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advanced Biomarker Assessment of Adipose Derived Stem Cells and Fibroblasts in Patients With and Without Pelvic Organ Prolapse
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.
Read the detailed description
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
- Pelvic Organ Prolapse
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Organ Prolapse | Patients having vaginal hysterectomy who demonstrate grade III-IV uterovaginal prolapse. | |
| Non Pelvic Organ Prolapse | Patients having vaginal hysterectomy who do not demonstrate uterovaginal prolapse. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advanced biomarker assessments will include messenger RNA sequencing.
RNA-Seq will determine if there are differences in mRNA or exon expression between cells from prolapse and normal patients, with focus on genes involved in connective tissue metabolism (e.g., collagens, MMPs, TIMPs, myofibroblast markers).
Measured: one year
Secondary outcomes (1)
2. Assess 3-D Biomaterial nanoscaffolds as potential carriers of ASC's to treat prolapse.
mRNA levels of ASC's in normal and prolapse patients will be assessed as markers for successful cell seeding on 3D-biomaterial nanoscaffolds and compared to cells under standard 2D-cell culture conditions that are used to generate clinical grade ASC's.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start29 Jun 2018
- Primary completion18 May 2020
- Study completion18 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johnny Yi, Mayo Clinic
- Investigators
- Johnny Yi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642054
- Sponsor's protocol ID
- 17-009172
- Status last verified
- Aug 2021
- First submitted
- 20 Aug 2018
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Biomarker Assessment of Adipose Derived Stem Cells and Fibroblasts in Patients With and Without Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT03642054
- Acronym / sponsor ID
- 17-009172
- Conditions
- Pelvic Organ Prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 18 May 2020 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic Organ Prolapse | – | –Patients having vaginal hysterectomy who demonstrate grade III-IV uterovaginal prolapse. |
| Non Pelvic Organ Prolapse | – | –Patients having vaginal hysterectomy who do not demonstrate uterovaginal prolapse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 6 patients with pelvic organ prolapse and 6 patients without pelvic organ prolapse.
Key inclusion criteria (3 listed)
- Patients undergoing vaginal hysterectomy for non-prolapse benign conditions and pelvic organ prolapse
- at least 18 years old
- Mayo Clinic patient
Key exclusion criteria (1 listed)
- °Patients who have a history of a recognized classic connective tissue disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Advanced biomarker assessments will include messenger RNA sequencing.
Time frame: one year
RNA-Seq will determine if there are differences in mRNA or exon expression between cells from prolapse and normal patients, with focus on genes involved in connective tissue metabolism (e.g., collagens, MMPs, TIMPs, myofibroblast markers).
1 secondary outcome
2. Assess 3-D Biomaterial nanoscaffolds as potential carriers of ASC's to treat prolapse.
Time frame: 1.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnny Yi, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advanced biomarker assessments will include messenger RNA sequencing. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.