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Characteristics of Patient Population With Endometriosis (20900)

Primary Purpose

Endometriosis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Questionnaires
Sponsored by
St. Louis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

13 Years - 55 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female patients
  • 13-55 years of age
  • Anyone seen at the Center for Endometriosis

Exclusion Criteria:

  • Prior bilateral salpingo-oophorectomy
  • post natural menopause
  • Significant mental or chronic systemic illness that might confound pain assessment or the inability to complete the study.

Sites / Locations

  • Saint Louis University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Endometriosis

Arm Description

Patients whom pathology results post surgery document endometriosis

Outcomes

Primary Outcome Measures

Quality of life, pain and fertility
(QOL) endometriosis health profile (EHP-5)

Secondary Outcome Measures

Full Information

First Posted
October 4, 2016
Last Updated
August 21, 2023
Sponsor
St. Louis University
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1. Study Identification

Unique Protocol Identification Number
NCT03002870
Brief Title
Characteristics of Patient Population With Endometriosis
Acronym
20900
Official Title
Characteristics of Patient Population With Endometriosis - A Prospective Database and BioBank
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to collect and analyze data on the characteristics of women who are seeking treatment for endometriosis, suspected endometriosis, pain and/or infertility as part of their standard medical care. Data collected will contribute to the development of guidelines for the surgical management of endometriosis. In addition, specimens will be collected for future testing regarding diagnosing, and/or staging of endometriosis, or suspected endometriosis, pain and infertility.
Detailed Description
Patients seen at Saint Louis University Center for Endometriosis (which has offices locations at St. Mary's, St. Luke's and the SLU-UMG clinic - all of which are in the SLU Epic system), and operated on for endometriosis, suspected endometriosis, pain and/or infertility at St. Mary's hospital (only). A preoperative questionnaire will be provided to the subject. Questions from the survey include information on baseline demographics, severity and type of pain, and previous medical and surgical history. Operative data will also be collected and analyzed. A post-operative questionnaire will be administered to the participants at 6 months, and then at regular yearly intervals after the surgery by a secure on-line process using the RedCap software. Improvement in quality of life and pain scores will be analyzed. Specimens will also be collected and stored for future testing regarding diagnosing, and/or staging of endometriosis, suspected endometriosis, pain and infertility.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endometriosis
Arm Type
Other
Arm Description
Patients whom pathology results post surgery document endometriosis
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Patients will receive questionnaires yearly to follow their QOL
Primary Outcome Measure Information:
Title
Quality of life, pain and fertility
Description
(QOL) endometriosis health profile (EHP-5)
Time Frame
every 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female patients 13-55 years of age Anyone seen at the Center for Endometriosis Exclusion Criteria: Prior bilateral salpingo-oophorectomy post natural menopause Significant mental or chronic systemic illness that might confound pain assessment or the inability to complete the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Yeung, MD
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Characteristics of Patient Population With Endometriosis

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