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

for the NICHD Cooperative Reproductive Medicine Network

Research output: Contribution to journalArticle

1 Citation (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1-6
Number of pages6
JournalContemporary Clinical Trials
Volume68
DOIs
StatePublished - May 1 2018

Fingerprint

Endometriosis
Biomarkers
Phenotype
National Institute of Child Health and Human Development (U.S.)
Reproductive Medicine
Gynecologic Surgical Procedures
Pelvic Pain
Hematologic Diseases
Endometrium
Routine Diagnostic Tests
Laparoscopy
Laparotomy
Infertility
Estrogens
Urine
Pharmacology
Cytokines
Biopsy
Serum
Therapeutics

Keywords

  • Biomarkers
  • Cytokines
  • Endometriosis
  • Micro RNA
  • Phenotyping

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Evaluation, validation and refinement of noninvasive diagnostic biomarkers for endometriosis (ENDOmarker) : A protocol to phenotype bio-specimens for discovery and validation. / for the NICHD Cooperative Reproductive Medicine Network.

In: Contemporary Clinical Trials, Vol. 68, 01.05.2018, p. 1-6.

Research output: Contribution to journalArticle

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