Evaluation, validation and refinement of noninvasive diagnostic biomarkers for endometriosis (ENDOmarker): A protocol to phenotype bio-specimens for discovery and validation

Contemp Clin Trials. 2018 May:68:1-6. doi: 10.1016/j.cct.2018.03.002. Epub 2018 Mar 7.

Abstract

Objective: Endometriosis is a chronic, estrogen dependent condition that affects 5-10% of reproductive aged women and is associated with pelvic pain and infertility. As the approach to therapy shifts from surgical ablation to pharmacological control, a non-surgical mode of diagnosis would be desirable. The ENDOmarker study was designed by the NICHD Reproductive Medicine Network (RMN) to obtain well characterized and phenotyped bio specimens in a standardized fashion from women with and without endometriosis.

Design: Development of a diagnostic test.

Setting: Academic medical centers.

Patients: This study will enroll up to 500 participants, and follow them for up to 5 months. Included subjects are aged 18-44, scheduled to undergo gynecologic surgery (laparoscopy/laparotomy) for clinical reasons.

Interventions: Presence and stage of endometriosis (or its absence) is characterized by visual examination at the time of surgery. Subjects will undergo extensive clinical evaluation pre-operatively and at visits one and four months postoperatively. Endometrial biopsy, blood, urine and disease specific questionnaires will be collected at each visit.

Main outcome: Samples will be placed in a bio-repository to be used to validate and optimize the clinical use of genomic classifiers of the endometrium alone or in combination with serum cytokines as a non-surgical composite marker of endometriosis.

Conclusion: This protocol can serve as a reference for objective collection of high quality bio specimens for discovery or validation of potential nonsurgical diagnosis of presence or severity of disease.

Keywords: Biomarkers; Cytokines; Endometriosis; Micro RNA; Phenotyping.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Biomarkers* / analysis
  • Biomarkers* / metabolism
  • Conservative Treatment / methods
  • Cytokines / blood*
  • Endometriosis* / diagnosis
  • Endometriosis* / drug therapy
  • Endometriosis* / metabolism
  • Endometrium / metabolism*
  • Female
  • Genitalia / metabolism*
  • Humans
  • Phenotype
  • Reproducibility of Results
  • Specimen Handling / methods*

Substances

  • Biomarkers
  • Cytokines