Inflammation and Cellular Immunity in Vaginal Tissue in P... | NCT03748693

Studies
Inflammation and Cellular Immunity in Vaginal Tissue in Patients With Pelvic Organ Prolapse

NCT03748693

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Nov 21, 2018Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Pelvic Organ Prolapse

Interventions

Hysterectomy
Colporrhaphy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2018Estimated

Primary Completion Date

Sep 2019Estimated

Completion Date

Sep 2019Estimated

First Submitted Date

Nov 19, 2018

First Submission Date that Met QC Criteria

Nov 19, 2018

First Posted Date

Nov 21, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2018

Last Update Posted Date

Nov 21, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to investigate the inflammatory and maturation processes of immature myeloid cells (IMC) in the vaginal tissue in women with advanced pelvic organ prolapse (POP) (stage III-IV) and in normal non-POP controls.

We hypothesize that the processes contributing to POP may be related to immune response and changes in myeloid cell populations and the cytokine environment.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
POP Group		Women with POP undergoing surgery in our OB/GYN department.	Procedure: Colporrhaphy
Non-POP Group		Women undergoing hysterectomy for other indications.	Procedure: Hysterectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hysterectomy	Procedure	Surgery performed on women with a variety of gynecological indications	Non-POP Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Immune response in POP	Tissue biopsy will analyzed for IMC and compared to control group	Two weeks
Cytokine environment in POP	Tissue biopsy will analyzed for cytokine environment and compared to control group	Two weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women with POP undergoing colporrhaphy
Women undergoing hysterectomy

Exclusion Criteria:

Autoimmune and connective tissue disorders
Cancer in genital tract

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Women attending our OB/GYN department because of POP and other gynecological disorders

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mariana Ordonez, MD	Contact	972-52-3243474		malo_mariana@hotmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D056887	Pelvic Organ Prolapse

Ancestor Terms

ID	Term
D011391	Prolapse
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007044	Hysterectomy

Ancestor Terms

ID	Term
D013509	Gynecologic Surgical Procedures
D013519	Urogenital Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided