Does "Aggressivity" of Endometriosis Correlate to Clinical History or Outcomes?

NCT02981043 | Completed

• 1 other identifier: 23924
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clinical studies so far have been limited, and larger volume and multi-center studies studies are needed. The purpose of this pilot study is to look for a clinical correlations between the aggressivity panel developed from biomarkers thought to affect the progression or aggressivity of endometriosis, pain and quality of life. Our goal with the study is find a correlation between the "aggressivity" of endometriosis with clinical factors determined in our study questionnaires. The "aggressivity panel" was pioneered by the EndoDiag lab in France, and was created using markers thought to affect the activity or progression of endometriosis. This information could lead to a better understanding of the disease, and ultimately lead to more targeted therapies. If a patient returns for a second surgery we will ask their permission to use their slides from their first and seconed surgery to compare. The tissue that is being removed during the surgery as standard of care to make slides for the research study (there will not be an endometrial biopsy performed for research purposes with the second surgery). The slides from surgery 1 \& surgery 2 will then be compared. If a clinical correlation is found with the aggressivity panel, the goal would be to create a local lab and tissue bank here in the United States that could provide a basis for collaborative national (even international) research. Also, if a correlation is found, future investigation will look at correlations of the aggressivity panel and fertility outcomes. Results of this pilot study will help to direct studies of treatment protocols of the various stages of aggressivity of endometriosis.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Survey: "how aggressive the endometriosis might be"

  At Surgery

Eligibility Criteria

• Age: 14 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Subjects will be identified, learn of the research and be recruited from the investigator's patient population.

You may qualify if:

• Female patients
• years of age
• Anyone seen at the Center for Endometriosis, including patients referred for the evaluation and management of pelvic pain
• Subjects must be having excision surgery for their endometriosis

You may not qualify if:

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

Sponsors & Collaborators

• St. Louis University: lead

Biospecimen

Retention: SAMPLES WITH DNA

1. Blood EDTA (about 10ml) (study related). 2. Peritoneal tissue (about 3-4 samples each the size of 1 tsp) (SOC) 3. Peritoneal fluid, if present (up to 100cc) (SOC) 4 Endometrial biopsy (1/4 to 1/2 inch long, (1/8 to 1/4 in width) (several SOC biopsies will be taken and one will be sent for research). 5\. Possibly small amount of ovarian tissue (if abnormal) (about size of 1 tsp) (SOC)

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: December 2, 2016
• Study Start: September 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 27, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share