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
About this trial
This is an interventional treatment trial for Endometriosis
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.
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
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
We'll reach out to this number within 24 hrs