Does "Aggressivity" of Endometriosis Correlate to Clinical History or Outcomes?
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

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.
    

Detailed description: 
      The study design is an investigator-initiated pilot, prospective cohort study (Canadian Task
      Force, II-3). Patients will not be randomized.

      Consecutive subjects from age 14-55 will be recruited and included in the study if they are
      seeking treatment of pain and with suspected or known endometriosis. Patients who are
      menopausal (either chemically-induced, natural or surgical) will not be included in the
      study. Patients who are pregnant are not eligible for surgery, and not eligible to be in the
      study. Subjects will be excluded if they are found not to have endometriosis confirmed by
      histology. All surgeries are performed at a single institution, St. Mary's Hospital.

      An ad hoc sample size calculation is not possible for this pilot study, since we have no
      historic data on which to base such a calculation. The goal is to acquire 45 panel results,
      as a reasonable amount of data for a pilot study, and given the funding available.

      Quality of life (measured by the 100-point scale and by the EHP-5) and pain indices (measured
      by the VAS scale) will be measured at up to six different time points: before surgery, six
      months after surgery, and one year after each surgery. At each time point you will compare
      quality of life and each pain index across the four aggressivity groups of low, moderate,
      medium, and high using analysis of variance (ANOVA) or the non-parametric Kruskal-Wallis test
      depending on the normality of the distributions. Pairwise comparisons will also be made using
      independent students t test or the non-parametric Kolmogorov-Smirnov test depending on the
      normality of the distributions.

      The follow-up time frame for each surgery will be 1 year. Patients will receive
      questionnaires pre op and at 6-months and 1 year for both the first surgery and the second
      surgery( if needed). The entire study will take about 4 years, including data analysis and
      publication. .

      This study is related to IRB #20900. Subjects who consent to participate in this study may
      also be consented to participate in 20900. The pre-operative and follow-up questionnaires,
      and the standardized tools relating to QOL and depression are the same as in IRB#20900.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects will be identified, learn of the research and be recruited from the investigator's
        patient population.
      
Biospecimen description: 
      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)